The Human Medicines Regulations 2012

• (a) issuing, where appropriate, a designation (“Promising Innovative Medicines designation”) in respect of a product under consideration for inclusion in the Scheme to the person who is or may in due course be responsible for placing the product on the market, after concluding based on early clinical and non-clinical data that the medicinal product may be eligible for inclusion in the Scheme because—

• (i) there is a life threatening or seriously debilitating condition and a high unmet need,

• (ii) the medicinal product is likely to offer a major advantage over methods of preventing, diagnosing or treating the condition already in use in the United Kingdom, and

• (iii) the potential adverse effects of the medicinal product are likely to be outweighed by the potential benefits, allowing for a reasonable expectation of a positive risk-benefit balance;

• (b) issuing, where appropriate, an opinion (“EAMS scientific opinion”) to a holder of a Promising Innovative Medicines designation to the effect that the holder is able—

• (i) to demonstrate that there is a life threatening or seriously debilitating condition and a high unmet need,

• (ii) to demonstrate that the medicinal product offers a major advantage over methods of preventing, diagnosing or treating the condition already in use in the United Kingdom,

• (iii) to demonstrate that the potential adverse effects of the medicinal product are outweighed by the potential benefits, allowing for a reasonable expectation of a positive risk-benefit balance,

• (iv) to supply the product to or within the United Kingdom (or a part thereof) for use as part of the Scheme, and

• (v) to manufacture, or secure the manufacturing of, the product to a consistent quality standard and in compliance with good manufacturing practice,

as a consequence of which the product is included in and may be supplied as part of the Scheme;

• (c) where it issues an opinion under sub-paragraph (b), attaching where appropriate conditions, which may be varied from time to time, to the access to the Scheme that the opinion gives (which may include conditions that are equivalent to requirements of Part 13);

• (d) revoking, pursuant to paragraph (3), opinions issued in accordance with sub-paragraph (b); and

• (e) renewing opinions issued in accordance with sub-paragraph (b) that would otherwise cease to have effect in accordance with regulation 167D(1).

• (3) The licensing authority may, if it is reasonable to do so, revoke an EAMS scientific opinion at any time (as a consequence of which, subject to regulation 167D(2), the product can no longer be supplied as part of the Scheme) if—

• (a) there is a breach of the conditions referred to in paragraph (2)(c);

• (b) there is a breach of regulation 167E to 167G; or

• (c) sufficient grounds no longer exist for inclusion of the product within the Scheme.

• (4) For the purposes of this regulation and regulations 167E and 167G, “authorised” has the meaning given in regulation 3(15), and (including the purposes of regulation 43(6)(aa)) “unauthorised” is to be construed accordingly.

EAMS scientific opinions ceasing to have effect

167D

• (1) Subject to paragraph (2), an EAMS scientific opinion ceases to have effect—

• (a) at the end of a period of one year beginning with the date on which it is issued;

• (b) on the granting of a marketing authorisation in respect of the product to which the opinion relates (but if the marketing authorisation is to apply in Great Britain only, the opinion can continue to have effect in Northern Ireland and vice versa);

• (c) on a variation of an existing marketing authorisation to take account of the advantage, identified in the opinion, because of which the product was included in the Early Access to Medicines Scheme (but if the variation is of a marketing authorisation that applies in Great Britain only, the opinion can continue to have effect in Northern Ireland and vice versa); or

• (d) if it is revoked by the licensing authority pursuant to regulation 167C(3).

• (2) The licensing authority may provide, in conditions attached in accordance with regulation 167C(2)(c), for a winding down period during which an EAMS scientific opinion is to continue to have effect in specified circumstances or for specified purposes (or both), notwithstanding that it has otherwise ceased to have effect by virtue of paragraph (1).

EAMS medicinal products: manufacture, assembly, importation, distribution and supply

167E

• (1) The prohibitions in regulation 46 (requirement for authorisation) do not apply in relation to an EAMS medicinal product if—

• (a) the medicinal product is supplied in response to an unsolicited order;

• (b) the medicinal product is manufactured and assembled in accordance with the specification (of the EAMS medicinal product) of a person who is a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber;

• (c) the medicinal product is for use by a patient for whose treatment that person is directly responsible in order to fulfil the special needs of that patient that relate to the advantage identified in the EAMS scientific opinion in respect of the product;

• (d) the EAMS scientific opinion issued in respect of the product and has not ceased to have effect in respect of it in accordance with regulation 167D; and

• (e) the conditions in paragraphs (2) to (4) are met.

• (2) If the EAMS medicinal product is—

• (a) manufactured or assembled (wholly or partly) in the United Kingdom, that manufacture or assembly must be—

• (i) by the holder of a manufacturer’s licence (which need not relate specifically to the manufacture of special medicinal products) or, if the licensing authority agrees, a manufacturing authorisation (within the meaning given in regulation 36(1) of the Medicines for Human Use (Clinical Trials) Regulations 2004) that relates to the manufacture or assembly of investigational medicinal products, and

• (ii) a function permitted by that manufacturer’s licence or manufacturing authorisation;

• (b) manufactured or assembled (wholly or partly) in an EEA State and imported into Northern Ireland (whether it is for sale or supply in Northern Ireland or Great Britain), that manufacture or assembly must be—

• (i) by a holder of a relevant authorisation in relation to the manufacture or assembly of medicinal products that has effect in accordance with the provisions of the 2001 Directive as implemented in that State, or

• (ii) if the medicinal product was manufactured or assembled as an investigational medicinal product in that State, by the holder of a relevant authorisation in relation to the manufacture or assembly of investigational medicinal products that has effect in accordance with the provisions of the EU Clinical Trials Regulation;

• (c) manufactured or assembled (wholly or partly) in an approved country for import and imported into Great Britain, that manufacture or assembly must be—

• (i) by a holder of a relevant authorisation in relation to the manufacture or assembly of medicinal products that has effect in accordance with the provisions applicable in that country, or

• (ii) if the medicinal product was manufactured or assembled as an investigational medicinal product in that country, by the holder of a relevant authorisation in relation to the manufacture or assembly of investigational medicinal products that has effect in accordance with the provisions applicable in that country,

and that importation must be by the holder of a wholesale dealer’s licence that permits importation into Great Britain of the product in question; or

• (d) manufactured or assembled (wholly or partly) outside the United Kingdom but sub-paragraph (b) or (c) does not apply to the importation of that product, the importation of that product must be—

• (i) by the holder of a manufacturer’s licence that relates to the importation of special medicinal products or, if the licensing authority agrees, investigational medicinal products, and

• (ii) a function permitted by that licence.

• (3) Written records of the manufacture or assembly of the EAMS medicinal product must be maintained by the manufacturer or assembler and be available to the licensing authority or to the enforcement authority on request.

• (4) If the EAMS medicinal product is distributed by way of wholesale dealing by a person (“P”), who has not, as the case may be, manufactured, assembled or imported the product as mentioned in paragraph (2), P must be the holder of a wholesale dealer’s licence that permits distribution of the product in question.

• (5) Where, with the agreement of the licensing authority, to ensure the ongoing availability of an EAMS medicinal product, an authorised product is assembled as that EAMS medicinal product and is supplied as part of the Scheme—

• (a) that authorised product is to be treated—

• (i) as an unauthorised product for the purposes of Part 13, and

• (ii) as that EAMS product for the purposes regulations 167G and 167H and Part 11; and

• (b) in any circumstances where that supply would not be an off label supply to which the prohibitions in regulation 46(2) did not apply (by operation of the common law), that supply is to be treated as an off label supply to which those prohibitions do not apply.

Advertising of EAMS medicinal products

167F

• (1) No advertisement relating to an EAMS medicinal product may be published by any person in respect of an advantage identified in the EAMS scientific opinion in respect of the product (although this does not preclude a person promoting the Early Access to Medicine Scheme itself).

• (2) In this regulation, “publish” has the meaning given in regulation 277(1) (interpretation: Part 14 advertising).

EAMS medicinal products: pharmacovigilance

167G

• (1) Subject to paragraphs (1A) and (1B), the EAMS scientific opinion holder must comply with the following pharmacovigilance requirements in respect of an EAMS medicinal product—

• (a) a risk management system must be agreed with the licensing authority and operated by the EAMS scientific opinion holder in accordance with the risk management plan;

• (b) the EAMS scientific opinion holder must record and maintain adverse reaction reports in respect of the EAMS medicinal product and must ensure that these reports are accessible (electronically or physically) at a single point within the United Kingdom;

• (c) the EAMS scientific opinion holder must submit electronically to the licensing authority—

• (i) a report on all serious suspected adverse reactions that occur within 15 days of receipt, and

• (ii) a report on all non-serious suspected adverse reactions that occur in the United Kingdom within 90 days of receipt,

and must ensure that the reports referred to in sub-paragraphs (i) and (ii) are in the format and content specified by Part 6 of Schedule 12A and, in the case of an MM medicinal product or a POC medicinal product, include the product’s batch number or other product identifier if no batch number is available;

• (d) the EAMS scientific opinion holder must—

• (i) establish procedures in order to obtain accurate and verifiable data for the scientific evaluation of suspected adverse reaction reports, and

• (ii) collect follow-up information on reports submitted under sub-paragraphs (c)(i) and (c)(ii) and submit it electronically to the licensing authority by way of an update to the original report within the specified time period;

• (e) the EAMS scientific opinion holder must submit periodic reports, in the manner specified in conditions attached under regulation 167C(2)(c), on the use of the EAMS medicinal product to the licensing authority, and where reasonably practicable, these reports must contain—

• (i) details of any suspected adverse drug reaction to the medicinal product,

• (ii) a summary of any significant new data on the quality, safety or efficacy of the medicinal product concerned,

• (iii) any proposed updates to the medicinal product information,

• (iv) all data the holder has relating to the volume of prescriptions, including an estimate of the population exposed to the medicinal product in the United Kingdom, and

• (v) a scientific evaluation of the risk-benefit balance of the medicinal product;

• (f) the EAMS scientific opinion holder must notify the licensing authority without delay if it detects any relevant changes in relation to the EAMS medicinal product, and for these purposes, “relevant changes” means—

• (i) new risks,

• (ii) risks that have changed, and

• (iii) changes to the risk-benefit balance; and

• (g) the EAMS scientific opinion holder must—

• (i) record all pharmacovigilance information required under this regulation,

• (ii) maintain those records for at least five years beginning on the date on which the EAMS scientific opinion ceases to have effect in accordance with regulation 167D(1) (subject to any winding down period provided for in accordance with regulation 167D(2)), and

• (iii) make those records available to the licensing authority or to the enforcement authority on request.

• (1A) In the case of an MM medicinal product, the periods of 15 and 90 days referred to in paragraph (1)(c) begin on the day following the day on which the holder of the scientific opinion gained knowledge of the reaction.

• (1B) In the case of a POC medicinal product, the periods of 15 and 90 days referred to in paragraph (1)(c) begin on the day following the day on which the holder of the scientific opinion gained knowledge of the reaction.

• (2) Nothing in paragraph (1) precludes the meeting of the requirements of that paragraph within systems or other arrangements established for other medicinal products (including for an authorised product the marketing authorisation of which may, in due course, be varied to take account of the advantage identified in the EAMS scientific opinion in respect of the EAMS medicinal product).

Early Access to Medicines Scheme: data collection

167H

• (1) Data may be collected and handled in respect of patients for the purposes of assessing the quality, safety and efficacy of an EAMS medicine as part of the Early Access to Medicines Scheme without the need for an authorisation granted by the licensing authority under the Clinical Trials Regulations, if—

• (a) informed consent is obtained from the patient and such consent is evidenced in writing, dated and signed, or otherwise marked by the patient as to indicate their consent; and

• (b) the licensing authority has consented to the data collection.

• (2) This is without prejudice to—

• (a) the need for the EAMS scientific opinion holder to obtain other approvals in respect of the handling of patient data, where appropriate; and

• (b) the powers that the EAMS scientific opinion holder and the licensing authority have to handle patient data (in accordance with the requirements of the Data Protection Act 2018) without the patient’s consent.

• (3) For the avoidance of doubt, patient consent to data collection or handling is not, and must not be made, a condition of the supply of an EAMS medicinal product to a patient as part of the Early Access to Medicines Scheme.

Use of non-prescription medicines in the course of a business

Mixing of general sale medicinal products

Record-keeping requirements

Exempt advanced therapy medicinal products

Parallel import licences

Exemption for certain radiopharmaceuticals

Supply in response to spread of pathogenic agents etc

Conditions of temporary authorisations under regulation 174

14B

A licence holder may only manufacture or assemble EAMS medicinal products if and to the extent that such products are required for the Early Access to Medicines Scheme.

23B

A licence holder may only import EAMS medicinal products if and to the extent that such products are required for the Early Access to Medicines Scheme.

33A

A licence holder may only import EAMS medicinal products if and to the extent that such products are required for the Early Access to Medicines Scheme.

Obligation on licensing authority to maintain list of medicinal products to which derogations have applied

345A

• (1) The licensing authority must publish a list of medicinal products to which the derogations described in Articles 5a, 8(2a) and (2b), 18a, 20 (second paragraph), 40(1a) and (3a), 48(3) and 104(3) of the 2001 Directive have applied.

• (2) The licensing authority must update the list referred to in paragraph (1) at least every six months.

Original pack dispensing

217B

• (1) Subject to paragraphs (2) to (4) and regulation 217C, for the purposes of this Part, the sale or supply of a prescription only medicine is in accordance with a prescription (and with the directions contained in the prescription) where—

• (a) a different quantity is sold or supplied to that ordered on the prescription in order to allow for the sale or supply of the medicine in its manufacturer’s original outer packaging; and

• (b) the sale or supply is otherwise in accordance with the prescription.

• (2) Paragraph (1) does not apply—

• (a) to the sale or supply of a different quantity to that ordered on the prescription in circumstances where the different quantity is more than 10% greater or more than 10% less than the quantity ordered on the prescription; or

• (b) in circumstances where—

• (i) a pharmacist is carrying out, supervising or authorising (under regulation 220B) the carrying out of the sale or supply and the pharmacist considers, or

• (ii) in Great Britian, a registered pharmacy technician is carrying out or supervising the sale or supply, pursuant to an authorisation (under regulation 220A) given by a pharmacist, and the registered pharmacy technician considers,

in the exercise of their professional skill and judgement, that the sale or supply of a different quantity to that ordered on the prescription may mean that the patient does not, or is not able to, follow the medication regimen intended by the prescriber.

• (3) Paragraph (2) does not apply to—

• (a) a medicine in a form that makes it not practicable to dispense in the exact quantity ordered;

• (b) a medicine in a container that has an integral means of application or from which it is not practicable to dispense an exact quantity;

• (c) a medicine that cannot be dispensed in the quantity ordered without adversely affecting the medicine.

• (4) Paragraphs (1) to (3) do not apply in relation to a supply of a prescription only medicine that is subject to—

• (a) in England, paragraph 8(1)(b) of Schedule 4, or paragraph 6(1)(b) of Schedule 7, to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013,

• (b) in Wales, paragraph 9(1)(b) of Schedule 5 to the National Health Service (Pharmaceutical Services) (Wales) Regulations 2020,

until those Regulations expressly apply paragraphs (1) to (3) to those supplies.

Original pack dispensing: medicinal products containing a relevant substance

217C

• (1) Subject to paragraph (2) and for the purposes of this Part, the sale or supply of a prescription only medicine containing a relevant substance is not in accordance with a prescription unless—

• (a) it is sold or supplied in its manufacturer’s original outer packaging; and

• (b) if the sale or supply is of a quantity that is different to the quantity which has been ordered on the prescription, it is sold or supplied in a quantity which is as close as possible to the quantity in which it has been ordered on the prescription.

• (2) Paragraph (1) does not apply where—

• (a) the sale or supply is—

• (i) by or under the supervision of or pursuant to an authorisation (under regulation 220B) given by a pharmacist, or

• (ii) in Great Britain, by or under the supervision of a registered pharmacy technician, pursuant to an authorisation (under regulation 220A) given by a pharmacist; and

• (b) the pharmacist (in a case to which paragraph (a)(i) applies) or registered pharmacy technician (in a case to which paragraph (a)(ii) applies) is satisfied that—

• (i) a risk assessment is in place that refers to the need for the patient to be sold or supplied the medicine containing a relevant substance in different packaging from its manufacturer’s original outer packaging (for example in a monitored dosage system); and

• (ii) unless the medicine containing a relevant substance is unauthorised (other than by reason of it being an authorised product that has ceased to be so as a result of a process of assembly), processes are in place to ensure the supply to or for the patient of the package leaflet.

• (3) In this regulation, “relevant substance” means any of the following—

• (a) sodium valproate;

• (b) valproic acid;

• (c) valproate semisodium.

Requirements for prescriptions: approved country health professional

Electronic prescriptions

Electronic Prescriptions: approved country health professionals

Original pack dispensing: Northern Ireland

217BA

• (1) Subject to paragraphs (2) to (4) and regulation 217CA, for the purposes of this Part, the sale or supply of a prescription only medicine is in accordance with a prescription (and with the directions contained in the prescription) where—

• (a) a different quantity is sold or supplied to that ordered on the prescription in order to allow for the sale or supply of the medicine in its manufacturer’s original outer packaging; and

• (b) the sale or supply is otherwise in accordance with the prescription.

• (2) Paragraph (1) does not apply—

• (a) to the sale or supply of a different quantity to that ordered on the prescription in circumstances where the different quantity is more than 10% greater or more than 10% less than the quantity ordered on the prescription; or

• (b) in circumstances where a pharmacist is carrying out , supervising or authorising (under regulation 220B) the carrying out of the sale or supply and the pharmacist considers, in the exercise of their professional skill and judgement, that the sale or supply of a different quantity to that ordered on the prescription may mean that the patient does not, or is not able to, follow the medication regimen as intended by the prescriber.

• (3) Paragraph (2) does not apply to—

• (a) a medicine in a form that makes it not practicable to dispense in the exact quantity ordered;

• (b) a medicine in a container that has an integral means of application or from which it is not practicable to dispense an exact quantity;

• (c) a medicine that cannot be dispensed in the quantity ordered without adversely affecting the medicine.

• (4) Paragraphs (1) to (3) do not apply in relation to a supply of a prescription only medicine that is subject to paragraphs 2(1) and (1A) of Schedule 2 to the Pharmaceutical Services Regulations (Northern Ireland) 1997,

until those Regulations expressly apply paragraphs (1) to (3) to those supplies.

Original pack dispensing: medicinal products containing a relevant substance

Original pack dispensing: medicinal products containing a relevant substance: Northern Ireland

217CA

• (1) Subject to paragraph (2) and for the purposes of this Part, the sale or supply of a prescription only medicine containing a relevant substance is not in accordance with a prescription unless—

• (a) it is sold or supplied in its manufacturer’s original outer packaging; and

• (b) if the sale or supply is of a quantity that is different to the quantity which has been ordered on the prescription, it is sold or supplied in a quantity which is as close as possible to the quantity in which it has been ordered on the prescription.

• (2) Paragraph (1) does not apply where—

• (a) the sale or supply is by or under the supervision of or pursuant to an authorisation (under regulation 220B) given by a pharmacist; and

• (b) the pharmacist is satisfied that—

• (i) a risk assessment is in place that refers to the need for the patient to be sold or supplied the medicine containing a relevant substance in different packaging from its manufacturer’s original outer packaging (for example in a monitored dosage system); and

• (ii) unless the medicine containing a relevant substance is unauthorised (other than by reason of it being an authorised product that has ceased to be so as a result of a process of assembly), processes are in place to ensure the supply to or for the patient of the package leaflet.

• (3) In this regulation, “relevant substance” means any of the following—

• (a) sodium valproate;

• (b) valproic acid;

• (c) valproate semisodium.

Requirements for prescriptions: approved country health professional

Electronic prescriptions

Electronic Prescriptions: approved country health professionals

Appropriate suppliers of naloxone products

237A

• (1) Regulations 214(1) and 220 do not apply to the supply of a naloxone product by an individual who is an appropriate supplier of naloxone products, if it is for an appropriate purpose.

• (2) For the purposes of paragraph (1), the following are appropriate suppliers of naloxone products—

• (a) a person employed or engaged in the provision of drug treatment services provided by or on behalf of, or under arrangements with, one of the following—

• (i) an NHS body,

• (ii) a local authority,

• (iii) the Secretary of State, or

• (iv) the Public Health Agency;

• (b) a person employed or engaged in the provision of services as part of the medical services of His Majesty’s forces;

• (c) a person employed or engaged by, or by an entity commissioned to provide drug treatment services by or on behalf of, one of the bodies listed below, if the listed body is satisfied that the person has undergone appropriate training in the storage and supply of naloxone products—

• (i) a police force in England, Wales or Scotland,

• (ii) the Police Service of Northern Ireland,

• (iii) a prison service,

• (iv) a provider of probation services, or

• (v) a provider of youth justice services;

• (d) a person who is one of the following—

• (i) a pharmacist,

• (ii) in England, Wales or Scotland, a registered pharmacy technician,

• (iii) a registered nurse,

• (iv) a registered midwife, or

• (v) a registered paramedic,

if that person has undergone appropriate training in the storage and supply of naloxone products; and

• (e) a person employed or engaged by a local naloxone provider, if that local naloxone provider is satisfied that the person has undergone appropriate training in the storage and supply of naloxone products.

• (3) For the purposes of this regulation, a local naloxone provider is an entity that has valid arrangements in place (“local naloxone arrangements”) with a naloxone supply network co-ordinator for the supply of naloxone products for an appropriate purpose.

• (4) For the purposes of this regulation, a naloxone supply network co-ordinator is an entity that has valid arrangements in place (“network creation arrangements”) with an appropriate national body as part of which the naloxone supply network co-ordinator creates and maintains a network of local naloxone providers that are willing to supply naloxone products for an appropriate purpose.

• (5) For—

• (a) local naloxone arrangements to be valid, a naloxone supply network co-ordinator must ensure that any putative local naloxone arrangements that it has contain arrangements that ensure; and

• (b) network creation arrangements to be valid, the appropriate national body must ensure that any putative network creation arrangements that it has contain arrangements that ensure,

the outcomes listed in paragraph (6).

• (6) Those outcomes are—

• (a) that only persons who are employed or engaged by the putative local naloxone provider and who have undergone appropriate training in the storage and supply of naloxone products are able to supply them under the putative local naloxone arrangements;

• (b) that any requirements that the appropriate national body has in respect of training in the storage and supply of naloxone products which are relevant to supply in accordance with this regulation are included in the putative local naloxone arrangements, and any such requirements are appropriate training for the purposes of paragraph (2)(e) (but see paragraph (8));

• (c) that a record is kept by the putative local naloxone provider of all the persons employed or engaged by them who are able to supply naloxone products under the putative local naloxone arrangements, and of their relevant training;

• (d) that the putative local naloxone provider has a named individual responsible at all times for—

• (i) the storage, any handling relating to storage and any handling relating to supply of naloxone products by or on behalf of the putative local naloxone provider under their putative local naloxone arrangements, and

• (ii) the maintenance of appropriate records of those activities by the putative local naloxone provider;

• (e) that any requirements that the appropriate national body has in respect of storage and any handling relating to supply of naloxone products by local naloxone providers, which arise out of or relate to supply in accordance with this regulation, are included in the putative local naloxone arrangements; and

• (f) that any requirements that the appropriate national body has in respect of the processing of information by local naloxone providers, including in respect of—

• (i) the records to be kept as part of local naloxone arrangements,

• (ii) the information to be derived from those records, and

• (iii) the provision of information to naloxone supply network co-ordinators, and the occasions on which and the frequency with which to do so,

which arise out of or relate to supply in accordance with this regulation, are included in the putative local naloxone arrangements.

• (7) For network creation arrangements to be valid, the appropriate national body must also ensure that any putative network creation arrangements that it has contain arrangements that ensure the following outcomes—

• (a) that any requirements that the appropriate national body has in respect of the processing of information by naloxone supply network co-ordinators, including in respect of—

• (i) the records to be kept as part of the network creation arrangements,

• (ii) the information to be derived from those records, and

• (iii) the provision of information to the appropriate national body, and the occasions on which and the frequency with which to do so,

which arise out of or relate to supply in accordance with this regulation, are included in the putative network creation arrangements; and

• (b) that any requirements that the appropriate national body has in respect of who may be a local naloxone provider, and how their status as such is recorded or advertised, are included in the putative network creation arrangements.

• (8) In order for training in the storage and supply of naloxone products to be appropriate for the purposes of this regulation, its outcome must be that a person completing the training successfully (T) has the following competencies—

• (a) understanding of the legal framework for supply in accordance with this regulation which is sufficient for the purposes of ensuring that T is able to administer naloxone products lawfully and where appropriate to supply them to another person for that other person to administer them lawfully, having been trained to do so by T;

• (b) understanding of the safe storage and safe handling of naloxone products which is sufficient for the purposes of ensuring—

• (i) that T is able to store and handle naloxone products safely and without compromising their efficacy, and

• (ii) if T is to supply those products to another person for that other person to store and handle them, that the other person is able to store and handle them safely, and without compromising their efficacy, having been trained to do so by T; and

• (c) understanding of how and when to administer naloxone products which is sufficient for the purposes of ensuring—

• (i) that T is able to do so safely, effectively and when appropriate, and

• (ii) if T is to supply those products to another person for that other person to administer them, that the other person is able to administer them safely, effectively and when appropriate, having been trained to do so by T,

and if the appropriate national body for where a supply takes place has determined that that is the outcome of particular training for a particular (or any) category of person, then for where that supply takes place that determination is conclusive evidence, or in Scotland sufficient evidence, that the training is appropriate training for that category of person.

• (9) The following are appropriate purposes for the purposes of this regulation—

• (a) the naloxone product is needed by the person to whom or for whom it is supplied for the purpose of saving life in an emergency;

• (b) in the reasonable expectation of the appropriate supplier of naloxone, the supply of the naloxone product is to enable it to be kept at a place where a person resides or which they frequent, in circumstances where that person may need, at that place—

• (i) to administer it to themselves in an emergency for the purposes of saving their own life, or

• (ii) to administer it to another person, or to have it administered to them, in accordance with regulation 238; or

• (c) in the reasonable expectation of the appropriate supplier of naloxone, the supply of the naloxone product is to enable it to be carried about by the person to or for whom it is supplied, that person being a person who may need it—

• (i) to administer it to themselves in an emergency for the purposes of saving their own life, or

• (ii) to administer it to another person, or to have it administered to them, in accordance with regulation 238.

• (10) Where, pursuant to this regulation, an appropriate supplier of naloxone mentioned in paragraph (2)(a) to (d) supplies a naloxone product—

• (a) that appropriate supplier of naloxone;

• (b) a provider of drug treatment services, medical services or other health care services that employs or engages the appropriate supplier of naloxone, if it is the entity that supplied the supplier with the naloxone product; or

• (c) a body listed in paragraph (2)(a) or (c), where that body provided or commissioned the drug treatment services or other health care services as part of which the appropriate supplier of naloxone supplied the naloxone product,

may provide an appropriate national body with any information about that supply, if that type of information, or information derived from that type of information, is information that a naloxone supply network co-ordinator would be required to supply to that body under network creation arrangements, it (or the information derived from it) being information included in requirements that the appropriate national body has as mentioned in paragraph (7)(a)(iii).

• (11) For the purposes of section 8(c) of the Data Protection Act 2018 (lawfulness of processing: public interest etc), provision of information in the circumstances described in paragraph (10) is to be considered necessary for the performance of a task carried out in the public interest.

• (12) For the purposes of this regulation, the following are appropriate national bodies—

• (a) in England, the Secretary of State;

• (b) in Scotland, the Scottish Ministers;

• (c) in Wales, the Welsh Ministers or Public Health Wales;

• (d) in Northern Ireland, the Public Health Agency or the Department of Health in Northern Ireland.

• (13) For the purposes of this regulation and regulation 238, any use of a naloxone product that is indicated in a marketing authorisation for the product is to be treated as being for the purpose of saving life, even if the use is for, or partially for, diagnosis.

Administration of certain medicines in an emergency

Administration of smallpox vaccine

Radioactive medicinal products

Exemptions in respect of certain herbal remedies

Exemption for medicinal products at high dilution

Exemption for certain homoeopathic medicinal products

Variation of a UKMA(GB) or a UKMA(UK)(Category 1)

Application of regulations 89 to 94

Packaging requirements: variation in accordance with regulation 68(11I)

257AA

• (1) This regulation applies where, in accordance with regulation 68(11I), the licensing authority thinks that a variation is necessary so that a UKMA(UK)(Category 2) is treated as a UKMA(GB) and separate UKMA(NI).

• (2) Where this regulation applies, the licensing authority may require that, in relation to the UKMA(GB), the information specified in paragraph 18B of Schedule 24 is replaced with a statement that the medicinal product is for sale or supply in Great Britain only.

257AB

The information specified in paragraph 18B of Schedule 24 is not required to appear on the packaging of a medicinal product released for sale or distribution before 1st January 2025, unless the product has been re-packaged or relabelled after that date.

Packaging Requirements: medicinal products required to bear safety features

Transitional Arrangements

Packaging requirements: advanced therapy medicinal products

Guidance as to packaging and package leaflets

Regulation-making power as to certain forms of labelling

Packaging requirements: specific provisions

Packaging requirements: information for blind and partially sighted patients

Package leaflets

Use of pictures and symbols etc

Labelling requirements for radionuclides

Leaflets relating to radionuclides

Homoeopathic medicines

Additional requirements for traditional herbal medicinal products

Language requirements etc

Submission of mock-ups of packaging and leaflets to licensing authority

Transitional provision relating to the Windsor Framework

347B

• (1) Schedule 33B contains transitional provision in relation to the implementation of the Windsor Framework.

• (2) In paragraph (1), “the Windsor Framework” means the part of the withdrawal agreement known as the Windsor Framework by virtue of Joint Declaration No. 1/2023 of 24 March 2023 made between the European Union and the United Kingdom in the Joint Committee established by the withdrawal agreement.

Amendments to existing law

Repeals and revocations

Prevalence of a condition in the United Kingdom

18B

The words “UK only”.

SCHEDULE33B — Transitional Provision in relation to the Windsor Framework

Existing marketing authorisations

1

• (1) Subject to sub-paragraphs (6), (13) and (14), a UKMA(GB) in force immediately before 1st January 2025 for a medicinal product in respect of which there is or has been in force an EU marketing authorisation, or which belongs to a category of medicinal product referred to in Article 3(1) or (2) of Regulation (EC) No 726/2004, has effect on and after that date as a UKMA(UK)(Category 1).

• (2) Subject to sub-paragraphs (6), (13) and (14), a UKMA(GB) in force immediately before 1st January 2025 for a generic medicinal product has effect on and after that date as a UKMA(UK)(Category 1) provided that there is or has been an EU marketing authorisation in force for the reference medicinal product.

• (3) Subject to sub-paragraphs (6), (13) and (14), a UKMA(GB) in force immediately before 1st January 2025 for a hybrid medicinal product has effect on or after that date as a UKMA(UK)(Category 1) provided that there is or has been an EU marketing authorisation in force in relation to the reference medicinal product.

• (4) Subject to sub-paragraphs (6), (13) and (14), a UKMA(GB) granted in accordance with regulation 53A or Article 10(4) and (6) of the 2001 Directive and in force immediately before 1st January 2025 for a biological medicinal product has effect on and after that date as a UKMA(UK)(Category 1) provided that there is or has been an EU marketing authorisation in force for the reference medicinal product.

• (5) Subject to sub-paragraphs (6), (13) and (14), any other UKMA(GB) in force immediately before 1st January 2025 has effect on and after that date as a UKMA(UK)(Category 2).

• (6) If the holder of a UKMA(GB) to which any of sub-paragraphs (1) to (5) applies notifies the licensing authority in writing before 1st January 2025 that it does not wish to be a holder of a UKMA(UK), the licensing authority must revoke the UKMA(GB) with effect from 1st January 2025.

• (7) A UKMA(UK) which has effect by virtue of any of sub-paragraphs (1) to (5) is treated as if it had been granted by the licensing authority on the same terms as those on which the UKMA(GB) was granted, including any conditions or restrictions subject to which, and retaining any benefits with which, the UKMA(GB) was granted and which remain in force immediately before 1st January 2025.

• (8) A UKMA(UK) in force immediately before 1st January 2025 for a generic medicinal product has effect on and after that date as a UKMA(UK)(Category 1) provided that there is or has been an EU marketing authorisation in force for the reference medicinal product.

• (9) A UKMA(UK) in force immediately before 1st January 2025 for a hybrid medicinal product has effect on or after that date as a UKMA(UK)(Category 1) provided that there is or has been an EU marketing authorisation in force in relation to the reference medicinal product.

• (10) A UKMA(UK) granted in accordance with regulation 53B or Article 10(4) and (6) of the 2001 Directive and in force immediately before 1st January 2025 for a biological medicinal product has effect on or after that date as a UKMA(UK)(Category 1) provided that there is or has been an EU marketing authorisation in force in relation to the reference medicinal product.

• (11) Any other UKMA(UK) in force immediately before 1st January 2025 has effect on and after that date as a UKMA(UK)(Category 2).

• (12) A UKMA(UK) which has effect by virtue of sub-paragraph (8) to (10) is treated as if it had been granted by the licensing authority on the same terms as those on which the UKMA(UK) in force before 1st January 2025 was granted, including any conditions or restrictions subject to which, and retaining any benefits with which, the UKMA(UK) was granted and which remain in force immediately before 1st January 2025.

• (13) Subject to sub-paragraph (14), a UKMA(GB) in force immediately before 1st January 2025 ceases to have effect on 1st January 2025 if—

• (a) there is a UKMA(NI) in force on 1st January 2025 in relation to the same medicinal product and with the same marketing authorisation holder, and

• (b) the holder of that UKMA(NI) has not made a request in writing to the licensing authority for the revocation of that UKMA(NI) before 30th September 2024.

• (14) However, where the holder of the UKMA(NI) referred to in sub-paragraph (13) has made a request in writing to the licensing authority for the revocation of that UKMA(NI) on or after 30th September and before 1st January 2025 and the licensing authority thinks that it is in the interest of patients’ health in the United Kingdom, the UKMA(GB) continues to have effect on 1st January 2025.

• (15) For the purposes of this paragraph, a medicinal product is a “hybrid medicinal product” if one or more of the circumstances set out in regulation 52B(1)(a) to (c) applied to the application for the UKMA for that product.

Existing applications for marketing authorisation

2

• (1) An application for a UKMA(GB) made before 1st January 2025 which has not been determined immediately before that date is to be treated on and after that date as an application for a UKMA(UK).

• (2) Sub-paragraph (3) applies where—

• (a) an application for a UKMA(UK) was made before 1st January 2025,

• (b) the application has not been determined immediately before that date,

• (c) the application was made under regulation 51B as it had effect on the date of the application, and

• (d) the reference medicinal product was of the description in paragraph (c)(ii) of the definition of that term in regulation 48(2) as it had effect on the date of the application.

• (3) Where this sub-paragraph applies, regulations 48 and 51B apply in respect of the application as they had effect immediately before 1st January 2025.

• (4) Sub-paragraph (5) applies where—

• (a) an application for a UKMA(UK) was made before 1st January 2025,

• (b) the application has not been determined immediately before that date,

• (c) the application was made under regulation 52B as it had effect on the date of the application, and

• (d) the reference medicinal product was of the description in paragraph (c)(ii) of the definition of that term in regulation 48(2) as it had effect on the date of the application.

• (5) Where this sub-paragraph applies, regulations 48 and 52B apply in respect of the application as they had effect immediately before 1st January 2025.

• (6) Sub-paragraph (7) applies where—

• (a) an application for a UKMA(UK) was made before 1st January 2025,

• (b) the application has not been determined immediately before that date,

• (c) the application was made under regulation 53B as it had effect on the date of the application, and

• (d) the reference medicinal product was of the description in paragraph (c)(ii) of the definition of that term in regulation 48(2) as it had effect on the date of the application.

• (7) Where this sub-paragraph applies, regulations 48 and 53B apply in respect of the application as they had effect immediately before 1st January 2025.

Post-authorisation processes

3

• (1) Where an application is made before 1st January 2025 for variation of a UKMA(GB) and that application has not been determined immediately before that date, if the authorisation has effect as a UKMA(UK)(Category 2) by virtue of paragraph 1(2), the application must be determined by the licensing authority as if it were an application for a variation of a UKMA(UK)(Category 1).

• (2) Where a holder of a UKMA(GB) has submitted a draft protocol under regulation 199(2) before 1st January 2025, if the authorisation has effect as a UKMA(Category 2) by virtue of paragraph 1(2), the obligations applied by regulations 198 to 202 apply in relation to the medicinal product concerned on and after 1st January 2025 as if the authorisation were a UKMA(UK)(Category 1).

Manufacturing of MM medicinal products

17A

A person may not manufacture or assemble an MM medicinal product unless—

• (a) it is specified in a manufacturer’s licence (MM); and

• (b) there is an MM master file relating to that product and it is manufactured or assembled in accordance with that master file.

Manufacturing of POC medicinal products

17B

A person may not manufacture or assemble a POC medicinal product unless—

• (a) it is specified in a manufacturer’s licence (POC); and

• (b) there is a POC master file relating to that product and it is manufactured or assembled in accordance with that master file.

Wholesale dealing in medicinal products

Approved country for import

Exemptions from requirement for wholesale dealer's licence

Mixing of medicines

Application for manufacturer's or wholesale dealer's licence

Factors relevant to determination of application for manufacturer's or wholesale dealer's licence

Grant or refusal of licence

Standard provisions of licences

Duration of licence

General power to suspend, revoke or vary licences

Procedure where licensing authority proposes to suspend, revoke or vary licence

Effect of suspension or variation relating to modular unit or POC site

27A

• (1) If the licensing authority suspends or varies a manufacturer’s licence (MM) in accordance with regulation 26(2)(d) so that manufacturing or assembly is suspended, or no longer authorised, at a modular unit, the licence holder may not approve that unit for the purpose of manufacturing or assembly of the MM medicinal product other than by way of an application under regulation 29.

• (2) If the licensing authority suspends or varies a manufacturer’s licence (POC) in accordance with regulation 26(2)(e) so that manufacturing or assembly is suspended, or no longer authorised, at a POC site, the licence holder may not approve that site for the purpose of manufacturing or assembly of the POC medicinal product other than by way of an application under regulation 29.

Suspension of licence in cases of urgency

Variation of licence on the application of the holder

Variation of MM master file

29A

Except where regulation 27A(1) applies, the holder of a manufacturer’s licence (MM) may amend the information in the MM master file provided in accordance with paragraph 1A(2)(a), (c) and (h) to (k) of Schedule 3 without applying to the licensing authority for a variation under regulation 29.

Variation of POC master file

29B

Except where regulation 27A(2) applies, the holder of a manufacturer’s licence (POC) may amend the information in the POC master file provided in accordance with paragraph 1B(2)(a), (b) and (g) to (j) of Schedule 3 without applying to the licensing authority for a variation under regulation 29.

Provision of information

Manufacturing and assembly of MM medicinal products: additional requirements

37A

In addition to the requirements in regulation 37, the holder of a manufacturer’s licence (MM) must ensure that—

• (a) the requirements in regulation 37(2) to (7), (9) and (11) are complied with in relation to manufacturing or assembly carried out at the modular units specified in the MM master file; and

• (b) only the MM medicinal products specified in the licence are manufactured or assembled at the modular units specified in the MM master file.

Manufacturing and assembly of POC medicinal products: additional requirements

37B

In addition to the requirements in regulation 37, the holder of a manufacturer’s licence (POC) must ensure that—

• (a) the requirements in regulation 37(2) to (7), (9) and (11) are complied with in relation to manufacturing or assembly carried out at the POC sites specified in the POC master file;

• (b) only the POC medicinal products specified in the licence are manufactured or assembled at the POC sites specified in the POC master file; and

• (c) a POC medicinal product specified in the licence is only manufactured at a POC site specified in the POC master file.

Imports from states other than EEA States / countries other than approved countries for import

Further requirements for manufacturer's licence

Obligation to provide information relating to control methods

Requirements as to qualified persons

Applications relating to POC medicinal products

50K

• (1) This regulation applies in relation to an application for a UK marketing authorisation for a relevant medicinal product that is a POC medicinal product.

• (2) The applicant for a UK marketing authorisation to which this regulation applies must, in addition to the material specified in regulation 50, provide to the licensing authority information about the measures the applicant envisages putting in place to ensure the follow up of the efficacy of the product and of any adverse reactions to it.

Application for UKMA(NI) relating to generic medicinal products

Application for UKMA(GB) relating to generic medicinal products

Application for UKMA(UK) relating to generic medicinal products

Application for UKMA(NI) relating to certain medicinal products that do not qualify as generic etc

Application for UKMA(GB) relating to certain medicinal products that do not qualify as generic etc

Application for UKMA(UK) relating to certain medicinal products that do not qualify as generic etc.

Application for UKMA(NI) relating to similar biological medicinal products

Application for UKMA(GB) relating to similar biological medicinal products

Application for UKMA(UK) relating to similar biological medicinal products

Applications relating to products in well-established medicinal use

Applications relating to new combinations of active substances

Applications containing information supplied in relation to another product with consent

Obligation to update information supplied in connection with parallel import licence application

74A

The holder of a UK marketing authorisation relating to an MM medicinal product must provide the holder of the manufacturer’s licence (MM) relating to that product with information in order to enable the licence holder to ensure that the manufacturer’s licence (MM) and MM master file relating to the product are consistent with the marketing authorisation at all times.

Obligation to provide information relating to methods of manufacture and control: POC medicinal products

74B

The holder of a UK marketing authorisation relating to a POC medicinal product must provide the holder of the manufacturer’s licence (POC) relating to that product with information in order to enable the licence holder to ensure that the manufacturer’s licence (POC) and POC master file relating to the product are consistent with the marketing authorisation at all times.

Obligation to provide information relating to safety etc

Obligation in relation to product information

Record-keeping obligations

Obligation to ensure appropriate and continued supplies

Post authorisation requirements in relation to UK marketing authorisations to which paediatric specific provisions apply

Post authorisation requirements in relation to UKMA(UK)(Category 1) for advanced therapy medicinal products

MM medicinal products: pharmacovigilance requirements

170A

• (1) Where the sale or supply of an MM medicinal product relies on the exemption in regulation 167, the person who sells or supplies the product must maintain a record of the information specified in paragraph (2) from the date that sale or supply first takes place until a date that is at least five years from the date on which supply of the product is discontinued.

• (2) The following information is specified for the purpose of paragraph (1)—

• (a) the source from which, and the date on which, the person obtained the product;

• (b) the person to whom, and the date on which, the sale or supply was made;

• (c) the quantity of the sale or supply;

• (d) the product’s batch number from which the sale or supply was made, or other product identifier if no batch number is available; and

• (e) details of any suspected adverse reaction to the product so sold or supplied of which the person is aware or subsequently becomes aware.

• (3) The person must make the record available for inspection by the licensing authority on request.

• (4) The person must submit electronically to the licensing authority—

• (a) a report on all serious suspected adverse reactions to the product that occur within 15 days of the day following the day on which the person gained knowledge of the reaction, and

• (b) a report on all non-serious suspected adverse reactions to the product that occur in the United Kingdom within 90 days of the day following the day on which the person gained knowledge of the reaction.

• (5) The person must ensure that the reports referred to in paragraph (4)—

• (a) are in the format and have the content specified in Part 6 of Schedule 12A; and

• (b) include the product’s batch number, or other product identifier if no batch number is available.

• (6) The person must, at the written request of the licensing authority, set up a risk management system designed to identify, characterise, prevent or minimise risks relating to the product.

POC medicinal products: pharmacovigilance requirements

170B

• (1) Where the sale or supply of a POC medicinal product relies on the exemption in regulation 167, the person who sells or supplies the product must maintain a record of the information specified in paragraph (2) from the date that sale or supply first takes place until a date that is at least five years from the date on which supply of the product is discontinued.

• (2) The following information is specified for the purpose of paragraph (1)—

• (a) the source from which, and the date on which, the person obtained the product;

• (b) the person to whom, and the date on which, the sale or supply was made;

• (c) the quantity of the sale or supply;

• (d) the product’s batch number from which the sale or supply was made, or other product identifier if no batch number is available; and

• (e) details of any suspected adverse reaction to the product so sold or supplied of which the person is aware or subsequently becomes aware.

• (3) The person must make the record available for inspection by the licensing authority on request.

• (4) The person must submit electronically to the licensing authority—

• (a) a report on all serious suspected adverse reactions to the product that occur within 15 days of the day following the day on which the person gained knowledge of the reaction, and

• (b) a report on all non-serious suspected adverse reactions to the product that occur in the United Kingdom within 90 days of the day following the day on which the person gained knowledge of the reaction.

• (5) The person must ensure that the reports referred to in paragraph (4)—

• (a) are in the format and have the content specified in Part 6 of Schedule 12A; and

• (b) include the product’s batch number, or other product identifier if no batch number is available.

• (6) The person must, at the written request of the licensing authority, set up a risk management system designed to identify, characterise, prevent or minimise risks relating to the product.

Exempt advanced therapy medicinal products

Parallel import licences

Exemption for certain radiopharmaceuticals

Supply in response to spread of pathogenic agents etc

Conditions of temporary authorisations under regulation 174

Packaging requirements: POC medicinal products

257CA

• (1) This regulation applies to a POC medicinal product that is the subject of a UKMA(UK)(Category 1) and not—

• (a) an advanced therapy medicinal product; and

• (b) to be administered in its entirety immediately after manufacture.

• (2) The information specified in Part 6 of Schedule 24 must appear—

• (a) on the outer packaging of a POC medicinal product to which this regulation applies; and

• (b) on the immediate packaging of that product, unless paragraph (3) or (4) applies to the packaging.

• (3) This paragraph applies to the immediate packaging if the packaging is in the form of a blister pack and is placed in outer packaging which complies with the requirements of Part 6 of Schedule 24.

• (4) This paragraph applies to the immediate packaging if the packaging is too small to display the information required by Part 6 of Schedule 24.

• (5) The information specified in Part 7 of Schedule 24 must appear on the immediate packaging to which paragraph (3) or (4) applies.

Guidance as to packaging and package leaflets

Regulation-making power as to certain forms of labelling

Packaging requirements: specific provisions

Packaging requirements: information for blind and partially sighted patients

Package leaflets

Use of pictures and symbols etc

Labelling requirements for radionuclides

Leaflets relating to radionuclides

Homoeopathic medicines

Additional requirements for traditional herbal medicinal products

Language requirements etc

Submission of mock-ups of packaging and leaflets to licensing authority

Manufacturer’s licences (MM)

1A

• (1) This paragraph applies to an application for a manufacturer’s licence relating to MM medicinal products.

• (2) In addition to the requirements in paragraph 1, the application must be accompanied by a dossier for each MM medicinal product to which the application relates, which includes, as a minimum, the following—

• (a) a description and means of identification of each modular unit at which manufacture or assembly of the MM medicinal product is to take place;

• (b) the location of each unit at which manufacturing or assembly of the MM medicinal product is to take place;

• (c) the location of each site at which operations related to the manufacture or assembly of the MM medicinal product are to take place;

• (d) a description of the process by which the licence holder will approve new modular units;

• (e) a description of the processes by which the licence holder will initiate, suspend and cease manufacturing or assembly of the product at a modular unit;

• (f) a description of the manufacturing, assembly and product release processes to take place at each modular unit;

• (g) a description of the arrangements for supervision and control by the licence holder of the manufacture or assembly operations at each modular unit;

• (h) a description of the arrangements for reporting of suspected adverse reactions from modular units to the MM control site;

• (i) the name and contact details of the person at the MM control site who is to be contacted in respect of manufacturing or assembly operations under the licence;

• (j) the name and contact details of the person to be contacted in respect of manufacturing or assembly operations at each modular unit;

• (k) the name and contact details of the person at the MM control site who is to be contacted in respect of quality operations under the licence;

• (l) the name and contact details of the person to be contacted in respect of quality operations at each modular unit; and

• (m) a description of the processes by which the licence holder will review and amend the MM master file for the product.

Manufacturer’s licence (POC)

1B

• (1) This paragraph applies to an application for a manufacturer’s licence relating to POC medicinal products.

• (2) In addition to the requirements in paragraph 1, the application must be accompanied by a dossier for each POC medicinal product to which the application relates, which includes, as a minimum, the following—

• (a) the location of each site at which manufacturing or assembly of the POC medicinal product is to take place;

• (b) the location of each site at which operations related to the manufacture or assembly of the POC medicinal product are to take place;

• (c) a description of the process by which the licence holder will approve new POC sites;

• (d) a description of the processes by which the licence holder will suspend and cease manufacturing or assembly of the POC medicinal product at a POC site;

• (e) a description of the manufacturing, assembly and product release processes to take place at each POC site;

• (f) a description of the arrangements for supervision and control by the licence holder of the manufacture or assembly operations at each POC site;

• (g) a description of the arrangements for reporting of suspected adverse reactions from POC sites to the POC control site;

• (h) the name and contact details of the person at the POC control site who is to be contacted in respect of manufacturing or assembly operations under the licence;

• (i) the name and contact details of the person to be contacted in respect of manufacturing or assembly operations at each POC site;

• (j) the name and contact details of the person at the POC control site who is to be contacted in respect of quality operations under the licence;

• (k) the name and contact details of the person who is to be contacted in respect of quality operations at each POC site; and

• (l) a description of the processes by which the licence holder will review and amend the POC master file for the product.

Part 1A — Manufacturer’s licence (MM)

14C

The provisions of paragraphs 14D to 14K are incorporated as additional standard provisions of a manufacturer’s licence (MM).

14D

The licence holder must maintain an MM master file for each MM medicinal product specified in the licence.

14E

An MM master file may relate to one MM medicinal product only.

14F

An MM master file must contain, as a minimum, the following information—

• (a) the information specified in paragraph 1A(2) of Schedule 3; and

• (b) the location and identification of any modular unit at which manufacturing or assembly of the MM medicinal product has commenced, has been suspended or has ceased, the date on which manufacturing or assembly commenced or ceased, and the dates on which it was suspended.

14G

The licence holder must ensure that the information contained in the MM master file is kept up to date, and consistent with any UK marketing authorisation for the product, at all times.

14H

The licence holder must make the MM master file available to the licensing authority at all times on request.

14I

The licence holder must submit to the licensing authority, at annual intervals, an update of any changes to the MM master file made in the previous 12 month period, the first update being required to be submitted no later than the date that is 12 months from the date on which the manufacturer’s licence (MM) was granted.

14J

The licence holder must keep under review the arrangements for supervision and control of the manufacture or assembly operations at each modular unit and, if the arrangements are found to be inadequate, ensure that appropriate remedial action is taken as soon as reasonably practicable.

14K

• (1) The licence holder must record all suspected adverse reactions to the MM medicinal product which are brought to the licence holder’s attention.

• (2) The licence holder must not refuse to consider reports of suspected adverse reactions to the product received electronically or by any other appropriate means from patients or from health care professionals.

• (3) The licence holder must report suspected adverse reactions identified under sub-paragraph (1) to the holder of the UK marketing authorisation, or the EAMS scientific opinion holder (as applicable), relating to the MM medicinal product as soon as reasonably practicable after the licence holder gains knowledge of the reaction.

Part 1B — Manufacturer’s Licence (POC)

14L

The provisions of paragraphs 14M to 14T are incorporated as additional standard provisions of a manufacturer’s licence (POC).

14M

The licence holder must maintain a POC master file for each POC medicinal product specified in the licence.

14N

A POC master file may relate to one POC medicinal product only.

14O

A POC master file must contain, as a minimum, the following information:

• (a) the information specified in paragraph 1B(2) of Schedule 3; and

• (b) the location of any POC sites at which manufacturing or assembly of the POC medicinal product has commenced, has been suspended or has ceased, the date on which manufacturing or assembly commenced or ceased, and the dates on which it was suspended.

14P

The licence holder must ensure that the information contained in the POC master file is kept up to date, and consistent with any UK marketing authorisation for the product, at all times.

14Q

The licence holder must make the POC master file available to the licensing authority at all times on request.

14R

The licence holder must submit to the licensing authority, at annual intervals, an update of any changes to the POC master file made in the previous 12 month period, the first update being required to be submitted no later than the date that is 12 months from the date on which the manufacturer’s licence (POC) was granted.

14S

The licence holder must keep under review the arrangements for supervision and control of the manufacture or assembly operations at each POC site and, if the arrangements are found to be inadequate, ensure that appropriate remedial action is taken as soon as reasonably practicable.

14T

• (1) The licence holder must record all suspected adverse reactions to the POC medicinal product which are brought to the licence holder’s attention.

• (2) The licence holder must not refuse to consider reports of suspected adverse reactions to the product received electronically or by any other appropriate means from patients or from health care professionals.

• (3) The licence holder must report suspected adverse reactions identified under sub-paragraph (1) to the holder of any UK marketing authorisation, or the EAMS scientific opinion holder (as applicable), relating to the POC medicinal product as soon as reasonably practicable after the licence holder gains knowledge of the reaction.

12B

In the case of an MM medicinal product or a POC medicinal product, the obligations in paragraphs 12(1)(a) and 12A(1)(a) may be satisfied by securing that each product has been manufactured and checked in accordance with these Regulations and the requirements of the marketing authorisation relating to the product.

PART 6 — Outer and Immediate Packaging: POC Medicinal Products for sale or supply in Great Britain only

54

The name of the medicinal product.

55

The strength and pharmaceutical form of the product.

56

Where appropriate, whether the product is intended for babies, children or adults.

57

The expiry date, including the year and month and, if applicable, the day or time in hours and minutes.

58

Where the product contains up to three active substances, the common name of each active substance.

59

A statement of the active substances in the product, expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names.

60

The pharmaceutical form and the contents by weight, by volume or by number of doses of the product.

61

A list of—

• (a) where the product is injectable or is a topical or eye preparation, all excipients; or

• (b) in any other case, those excipients known to have a recognised action or effect and included in the guidance published under regulation 257D that is applicable to such products.

62

The method of administration of the product and if necessary the route of administration.

63

Where appropriate, space for the prescribed dose to be indicated.

64

A warning that the product must be stored out of the reach and sight of children.

65