Legalize / United Kingdom / Statutory-Instrument

The Human Medicines Regulations 2012

Type Statutory-Instrument

Publication 2012-07-19

Last updated 2026-03-31

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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articles 4

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(vii) study size: study size, rationale for any study size calculation and any method for attaining projected study size,

(viii) data transformation: transformations, calculations or operations on the data, including how quantitative data were handled in the analyses and which groupings were chosen and why,

(ix) statistical methods: description of the following items—

(aa) main summary measures,

(bb) all statistical methods applied to the study,

(cc) any methods used to examine subgroups and interactions,

(dd) how missing data were addressed,

(ee) any sensitivity analyses, and

(ff) any amendment to the plan of data analysis included in the study protocol, with rationale for the change, and

(x) quality control: mechanisms to ensure data quality and integrity;

(j) results: comprising the following subsections—

(i) participants, namely numbers of study subjects at each stage of study: in the case of a systematic review or meta-analysis, number of studies screened, assessed for eligibility and included in the review with reasons for exclusion at each stage,

(ii) descriptive data: characteristics of study participants, information on exposures and potential confounders and number of participants with missing data. In the case of a systematic review or meta-analysis, characteristics of each study from which data were extracted,

(iii) outcome data: numbers of study subjects across categories of main outcomes,

(iv) main result: unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision and where relevant, estimates of relative risk must be translated into absolute risk for a meaningful time period,

(v) other analyses, and

(vi) adverse events and adverse reactions;

(k) discussion which must include—

(i) key results with reference to the study objectives, prior research in support of and conflicting with the findings of the completed post-authorisation safety study, and, where relevant, the impact of the results on the risk–benefit balance of the product,

(ii) limitations of the study taking into account circumstances that may have affected the quality or integrity of the data, limitations of the study approach and methods used to address them, sources of potential bias and imprecision, and validation of the events; both the direction and magnitude of potential biases must be discussed,

(iii) interpretation of results, considering objectives, limitations, multiplicity of analyses, results from similar studies and other relevant evidence, and

(iv) generalisability; and

(l) references.

PART 4 — Outer and immediate packaging: advanced therapy medicinal products ...

34

The name of the advanced therapy medicinal product which is the international non-proprietary name, or if none, the common name.

35

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

36

The expiry date in clear terms including the year and month and, if applicable, day.

37

A description of the active substance, expressed qualitatively and quantitatively.

38

Where the product contains tissues and cells of human or animal origin—

(a) a statement that the product contains such cells or tissues; and

(b) a short description of the cells or tissues and of their specific origin, including the species of animal in cases on non-human origin.

39

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

40

A list of excipients, including preservative systems.

41

The method of use, application, administration or implantation and, if appropriate, the route of administration, with space provided for the prescribed dose to be indicated.

42

A special warning that the product is to be stored out of the sight and reach and children.

43

Any special warning necessary for the particular product.

44

Any special storage precautions.

45

Specific precautions relating to the disposal of the unused product or of waste derived from the product and, where appropriate, reference to any appropriate collection system.

46

The name and address of the holder of the UK marketing authorisation and, where applicable, the name of the representative appointed by the holder to represent him.

47

The UK marketing authorisation number.

48

The manufacturer's batch number.

49

The unique donation code assigned by a tissue establishment pursuant to—

(a) paragraph 1 of Schedule 3A to the Human Fertilisation and Embryology Act 1990, as regards human gametes and embryos; and

(b) paragraph 1 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007, as regards other human tissues and cells.

50

Where the exempt advanced therapy medicinal product is for autologous use, the unique patient identifier and the words “for autologous use only”.

PART 5 — Immediate packaging: blister packs and small packaging (advanced therapy medicinal products ...)

51

The information specified in Part 2.

52

The unique donation code assigned by a tissue establishment pursuant to—

(a) paragraph 1 of Schedule 3A to the Human Fertilisation and Embryology Act 1990, as regards human gametes and embryos; and

(b) paragraph 1 of Schedule 2 to the Human Tissue (Quality and Safety for Human Application) Regulations 2007, as regards other human tissues and cells.

53

Where the exempt advanced therapy medicinal product is for autologous use, the unique patient identifier and the words “for autologous use only”.

Part 3 — Advanced therapy medicinal products ...

18

The name of the advanced therapy medicinal product.

19

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

20

The common name of the advanced therapy medicinal product.

21

The therapeutic group, or type of activity, of the product, in terms easily comprehensible for the patient.

22

Where the product contains cells or tissues, a description of those cells or tissues and of their specific origin, including the species of animal in cases of non-human origin.

23

Where the product contains medical devices or active implantable medical devices, a description of those devices and their specific origin.

24

The product's therapeutic indications.

25

A list of information which is necessary before the medicinal product is taken or used, including—

(a) contra-indications;

(b) appropriate precautions for use;

(d) interactions with other substances, including alcohol, tobacco and foodstuffs which may affect the action of the product;

(e) special warnings; if any, relating to the product.

26

The list mentioned in paragraph 25 must—

(a) take into account the special requirements of particular categories of users (including, in particular, children, pregnant or breastfeeding women, the elderly and persons with specific pathological conditions);

(b) mention, if appropriate, possible effects on the ability to drive vehicles or operate machinery; and

(i) if knowledge of the excipients is important for the safe and effective use of the product; and

(ii) the excipients are included in the guidance published under regulation 257D.

27

Instructions for proper use of the product including in particular—

(a) the dosage;

(b) the method of use, application, administration or implantation and, if necessary, the route of administration;

(c) the frequency of administration (including, if necessary, specifying the times at which the product may or must be administered);

(d) the duration of treatment if this is to be time limited;

(e) symptoms of an overdose and the action, if any, to be taken in the case of an overdose;

(f) what to do if one or more doses have not been taken;

(g) a specific recommendation to consult a doctor or pharmacist, as appropriate, for further explanation of the use of the product.

28

A description of the adverse reactions which may occur in normal use of the medicinal product and, if necessary, the action to be taken in such a case.

29

A reference to the expiry date printed on the packaging of the product with—

(a) a warning against using the product after that date;

(b) if appropriate, details of special storage precautions to be taken;

(d) the full qualitative and quantitative composition;

(e) the name and address of the UK marketing authorisation holder and, if applicable, the name of the holder's appointed representative; and

(f) the name and address of the manufacturer.

30

The date on which the package leaflet was last revised.

2A

In relation to an advertisement in Great Britain (other than an advertisement falling within the exception in regulation 296) where the medicinal product concerned is authorised under a UKMA(GB), a statement that the product concerned is authorised under a UKMA(GB).

SCHEDULE 33A — Transitional provision in relation to EU Exit

PART 1 — Interpretation

1

In this Schedule—

“the COMP” means the Committee for Orphan Medicinal Products of the EMA, established under Article 4 of the Orphan Regulation;

“converted EU marketing authorisation” has the meaning given in paragraph 6(1) and (2);

“the Paediatric Regulation” means Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004, as it has effect in EU law;

“the Paediatric Committee” means the committee of the EMA established under Article 3 of the Paediatric Regulation;

“the Pharmacovigilance Risk Assessment Committee” means the Committee of the EMA established by Article 56(1)(aa) of Regulation (EC) No 726/2004; and

“Regulation (EC) No 507/2006” means Commission Regulation (EC) No 507/2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council, as it has effect in EU law.

PART 2 — Manufacturing, wholesale dealing and brokering

Wholesale dealer's licence used to distribute a medicinal product imported from an EEA State before IP completion day

2

(1) Subject to sub-paragraphs (2) and (3), a person (“P”) who is the holder of a wholesale dealer's licence which—

(a) was granted before IP completion day by the licensing authority;

(b) was in force immediately before IP completion day and remains in force on IP completion day (whether or not it is suspended); and

(c) was used by P to distribute a medicinal product, which was imported from an EEA State, by way of wholesale dealing, or to possess a medicinal product imported from an EEA State for such a purpose,

is deemed on and after IP completion day to hold a wholesale dealing licence granted under Part 3 (manufacture and distribution of medicinal products and active substances) that permits the operation of importing medicinal products from an approved country for import for the purposes specified in paragraph (c).

(2) After the end of the period of 6 months beginning with IP completion day, P is deemed to continue hold a wholesale dealer's licence that permits the operation of importing medicinal products from an approved country for import by virtue of sub-paragraph (1) only if, before the end of that period, P has notified the licensing authority in writing of—

(a) P's intention to continue to import medicinal products from an approved country for import; and

(b) either—

(i) P's intention to appoint a responsible person (import) who will carry out the functions under regulation 45AA(4) (requirement as to responsible persons where licence holder imports from an approved country for import) in respect of the licence, or

(ii) that P will only import medicinal products from an approved country for import to which an exemption in regulation 45AA(2) applies.

(3) Unless P has notified the licensing authority as provided for in sub-paragraph (2)(b)(ii), after the end of the period of 2 years beginning with IP completion day, P is deemed to continue to hold a wholesale dealer's licence that permits the operation of importing medicinal products from an approved country for import by virtue of sub-paragraph (1) only if, before the end of that period, P has notified the licensing authority in writing of the name, address and qualifications of a person who—

(a) is included in the register under regulation 45AB(1); and

(b) will carry out the functions under regulation 45AA(4) in respect of the licence.

(4) From IP completion day, until the date on which P notifies the licensing authority of the information specified in sub-paragraph (3), the responsible person in respect of that licence under regulation 45 must carry out the functions under regulation 45AA(4).

(5) As soon as reasonably practicable after receipt of the information specified in paragraph (3), the licensing authority must provide P with written notice that the responsible person (import) is named on the licence.

(6) Where P has notified the licensing authority as provided for in sub-paragraph (2)(b)(ii), the licensing authority must, as soon as reasonably practicable, notify P in writing that the wholesale dealer's licence includes import of a medicinal product from an approved country for import limited to medicinal products to which an exemption in regulation 45AA(2) applies.

Approved country for import list on IP completion day (regulation 18A)

3

(1) For the purposes of regulation 18A(1) (approved country for import), during the transitional period, the licensing authority must publish an approved country for import list that includes each EEA State in it.

(2) The licensing authority must not, before the end of the transitional period, exercise its power under regulation 18A(3) to remove an EEA State from the approved country for import list.

(3) In this paragraph, “the transitional period” is the period of two years beginning with IP completion day.

Qualified persons and approved country for batch testing list on IP completion day (Schedule 7)

4

(1) Sub-paragraph (2) applies to a person who—

(a) is acting as a qualified person immediately before IP completion day; and

(b) satisfies the requirements of Part 1 of Schedule 7 (qualification requirements for qualified persons) immediately before IP completion day as they had effect at that time.

(2) The person is to be treated on and after IP completion day as continuing to satisfy the requirements of Part 1 of Schedule 7 if the person would otherwise fail to do so as a result of amendments made to that Part by the EU Exit Regulations.

(3) For the purposes of paragraph 14(1)(b) of Schedule 7 (obligations of qualified person), for the transitional period, the licensing authority is deemed to have made appropriate arrangements with—

(a) each EEA State;

(b) Australia;

(d) Israel;

(e) Japan;

(f) New Zealand;

(g) Switzerland; and

(h) the United States of America,

and the licensing authority must, on IP completion day, publish a list that includes those countries under paragraph 14(3) of Schedule 7.

(4) The licensing authority may, in respect of any country specified in sub-paragraph (3)(b) to (h), include that country in the list subject to a condition or restriction as provided for in paragraph 14(4) of Schedule 7, insofar as that condition or restriction was reflected in the appropriate arrangements that existed immediately before IP completion day under Article 51(2) of the 2001 Directive.

(5) The licensing authority must not, before the end of the transitional period, exercise its powers under paragraph 14(6) of Schedule 7 to remove an EEA State from the list it publishes.

(6) In this regulation, “the transitional period” is the period of two years beginning with IP completion day.

List of countries with equivalent regulatory standards as to the manufacturing of active substances on IP completion day (regulation 45O(6) to (9))

5

(1) For the purposes of regulation 45O(6) (requirements for registration as an importer, manufacturer or distributor of active substances), for the transitional period, the licensing authority must publish a list that includes the following countries—

(a) each EEA State;

(b) Australia;

(d) Israel;

(e) Japan;

(ea) Republic of Korea;

(f) Switzerland; and

(g) the United States of America.

(2) The licensing authority must not, before the end of the transitional period, exercise its power under regulation 45O(9) to remove an EEA State from the list it publishes.

(3) In this paragraph, “the transitional period” is the period of two years beginning with IP completion day.

PART 3 — Transitional provision in respect of conversion of EU marketing authorisations in force immediately before IP completion day

Conversion of EU marketing authorisations in force before IP completion day

6

(1) This paragraph applies in relation to an EU marketing authorisation which was in force immediately before IP completion day.

(2) An EU marketing authorisation to which this paragraph applies—

(a) insofar as it authorises sale or supply of a medicinal product in Great Britain, has effect on and after IP completion day as a UKMA(GB) granted under regulation 49(1) of these Regulations (but, insofar as it authorises sale or supply of a medicinal product in Northern Ireland, continues to operate in Northern Ireland as an EU marketing authorisation); and

(b) is referred to in this Part as a “converted EU marketing authorisation”.

(3) If the holder of an EU marketing authorisation to which this paragraph applies notifies the licensing authority in writing before the end of the period of 21 days beginning with IP completion day that it does not wish to be the holder of a converted EU marketing authorisation, the licensing authority must revoke the converted EU marketing authorisation with effect from the date of receipt of the notification.

(4) A converted EU marketing authorisation—

(a) is treated as if it had been granted by the licensing authority under regulation 49(1) on the same terms as those on which the EU marketing authorisation was granted, including any conditions or restrictions subject to which the EU marketing authorisation was granted and which remain in force immediately before IP completion day;

(b) is treated, for the purposes of regulations 65 or 65B (validity of UK marketing authorisation), as if it had been granted by the licensing authority on the date that the EU marketing authorisation took effect;

(c) is treated for the purposes of regulation 67(1) (failure to place on the market) as if it had been granted on IP completion day, and the period of three years referred to in regulation 67(2) is treated as having started on IP completion day;

(d) is treated for the purposes of determining the relevant fee period for the purposes of Schedule 4 to the Fees Regulations (periodic fees for marketing authorisations) as if it had been granted by the licensing authority on the date that the EU marketing authorisation took effect;

(e) is treated, for the purposes of the reference to the date of grant in regulation 27A(a) of the Fees Regulations (fees for renewals of a marketing authorisation) as if it had been granted on the date that the EU marketing authorisation took effect;

(f) retains, for the purposes of regulation 51A(1) and (6), the benefit of any remaining periods of data or marketing exclusivity (if any) from which the holder benefitted immediately before IP completion day;

(g) retains the benefit of any decision by the EMA to exempt the holder from Articles 14(4) or (5) of Regulation (EC) No 726/2004 (failure to place on the market), and that decision is treated as if it had been made by the licensing authority under regulation 67(3); and

(h) remains subject to—

(i) any suspension of the EU marketing authorisation that is in force immediately before IP completion day,

(ii) any post-authorisation obligations imposed after it was granted, and which remain in force immediately before IP completion day, and

(iii) any variation to its terms which were granted or accepted before IP completion day.

(5) For the purposes of this paragraph, an EU marketing authorisation is in force, even if that authorisation is suspended immediately before IP completion day.

(6) A converted EU marketing authorisation to which this paragraph applies which—

(a) was granted as a conditional marketing authorisation within the meaning of Article 1 of Regulation (EC) No 507/2006; and

(b) remains such a conditional marketing authorisation immediately before IP completion day,

has effect on and after IP completion day as a UK marketing authorisation granted under regulation 58F.

(7) A converted EU marketing authorisation to which this paragraph applies which relates to a medicinal product which—

(a) was designated as an orphan medicinal product by the European Commission pursuant to Article 5 of the Orphan Regulation; and

(b) remains in the Community register of Orphan Medicinal Products as referred to in that Article immediately before IP completion day,

has effect on and after IP completion day as a UK marketing authorisation granted under regulation 58C and retains, for the purposes of regulation 58D, the benefit of any period of marketing exclusivity from which the holder benefitted immediately before IP completion day under Article 8 of the Orphan Regulation.

Classification of converted EU marketing authorisations

7

For the purposes of regulation 62 (classification of UK marketing authorisation), it is a term of a converted EU marketing authorisation that the product to which the authorisation relates is to be available—

(a) in a case where the product was classified in its EU marketing authorisation immediately before IP completion day as a prescription only medicine, the product is to be available only on prescription;

(b) in a case where the product was not so classified and the licensing authority has determined that the product should be available on general sale, the product is to be available on general sale; or

Obligations of licensing authority in connection with converted EU marketing authorisations

8

(1) The licensing authority must, before the end of the period of 7 days beginning with IP completion day, notify the holders of converted EU marketing authorisations—

(a) that the EU marketing authorisation is converted to a UK marketing authorisation; and

(b) that the holder may notify the licensing authority in accordance with paragraph 6(3) that it does not wish to be the holder of a UK marketing authorisation.

(2) The licensing authority must, as soon as reasonably practicable after the end of the period referred to in paragraph 6(3), publish a list of converted EU marketing authorisations.

(3) The list mentioned in sub-paragraph (2) must specify which converted EU marketing authorisations have been revoked in accordance with paragraph 6(3).

Obligations of holders of converted EU marketing authorisations

9

(1) A holder of a converted EU marketing authorisation must submit to the licensing authority, before the end of the period of one year beginning with IP completion day, the information described in sub-paragraph (3).

(2) The obligation in sub-paragraph (1) is subject to any requirement imposed by the licensing authority to provide that information before the end of a shorter period specified by the licensing authority under paragraph 10(1).

(3) The information which must be submitted in accordance with sub-paragraph (1) (referred to in this paragraph as the “baseline data”) is—

(a) such information concerning the product to which the converted EU marketing authorisation relates as may be specified in writing for this purpose and published by the licensing authority on or before IP completion day;

(b) notification of whether or not the product to which the converted EU marketing authorisation relates—

(i) is on the market in the United Kingdom at the time the notification is given, or

(ii) if not, whether the product has been on the market in the United Kingdom at any time on or after IP completion day and if so, the date on which it was withdrawn from the United Kingdom market.

(4) In this Part, the date on which the holder of a converted EU marketing authorisation complies with the obligation in sub-paragraph (1), or with any requirement imposed by the licensing authority under paragraph 10(1) to provide all of the baseline data before the end of a period shorter than the period of one year beginning with IP completion day, is referred to as “the data submission date”.

Powers of licensing authority in connection with provision of information

10

(1) If the licensing authority requests a holder of a converted EU marketing authorisation to submit all or part of the baseline data at any time before the expiry of the period of one year beginning with IP completion day, the holder must supply the information within the time period specified by the licensing authority in its request.

(2) If the licensing authority requests a holder of a converted EU marketing authorisation to provide any other information relating to the EU marketing authorisation, the holder must supply the information within the time period specified by the licensing authority in its request.

Variations of converted EU marketing authorisations notified or applied for before IP completion day

11

(1) This paragraph applies where, before IP completion day—

(a) a holder of a converted EU marketing authorisation has notified the EMA of, or made an application to the EMA for, a variation of the EU marketing authorisation to which the converted EU marketing authorisation applies under Chapter III of Regulation (EC) No 1234/2008, or has made an application to the EMA for an extension of that EU marketing authorisation in accordance with Article 19 of that Regulation;

(b) the procedures specified in Article 17 of that Regulation (measures to close the procedures of Articles 14 to 16) have not concluded, or, in the case of an extension, no final decision has been made by the European Commission in relation to the application; and

(c) the holder of the converted EU marketing authorisation wishes the variation to be made to the converted EU marketing authorisation.

(2) Where the variation is a minor variation of Type IA—

(a) the variation may be implemented in relation to the converted EU marketing authorisation at any time on or after the time at which it may be implemented in relation to the EU marketing authorisation to which the converted EU marketing authorisation relates;

(b) the holder of the converted EU marketing authorisation must (subject to paragraph 13), include in the baseline data—

(i) a summary of the variation, and

(ii) if the notification has been rejected by the EMA, an indication of that fact; and

(c) the variation to the converted EU marketing authorisation is deemed to be accepted unless the licensing authority notifies the holder in writing before the end of the period of 30 days beginning with the data submission date that the variation is rejected, in which case the holder must cease to apply the rejected variation immediately after receipt of the notification.

(3) Where the variation is a minor variation of Type IB—

(a) the variation may be implemented in relation to the converted EU marketing authorisation at any time on or after the time at which it may be implemented in relation to the EU marketing authorisation to which the converted EU marketing authorisation relates;

(b) if the variation has not been rejected by the EMA, the holder of the converted EU marketing authorisation must (subject to paragraph 13) include a copy of the notification in the baseline data; and

(c) the variation to the converted EU marketing authorisation is deemed to be accepted unless the licensing authority notifies the holder in writing before the end of the period of 30 days beginning with the data submission date that the variation is rejected, in which case the holder must cease to apply the rejected variation immediately after receipt of the notification.

(4) Sub-paragraph (5) applies where—

(a) the variation is a major variation of Type II or an extension; and

(b) before IP completion day the Committee for Medicinal Products for Human Use gave a positive final opinion in relation to the application with which the United Kingdom concurred.

(5) Where this sub-paragraph applies—

(a) the variation may be implemented in relation to the converted EU marketing authorisation at any time on or after the time at which it may be implemented in relation to the EU marketing authorisation to which the converted EU marketing authorisation relates;

(b) the holder of the converted EU marketing authorisation must (subject to paragraph 13) include a copy of the application in the baseline data; and

(i) treat the variation as accepted, and, if the variation affects the terms of the converted EU marketing authorisation, amend those terms accordingly; or

(ii) notify the holder of the converted EU marketing authorisation before the end of the period of 30 days beginning with the data submission date that the variation is rejected, in which case the holder must cease to apply the rejected variation immediately after receipt of the notification.

(6) Sub-paragraph (7) applies where—

(a) the variation is a major variation of Type II or an extension; and

(b) before IP completion day the Committee for Medicinal Products for Human Use had not given any opinion in relation to the application, or had given a negative final opinion in relation to it, or had given a positive final opinion but the United Kingdom recorded a divergent opinion.

(7) Where this paragraph applies—

(a) the holder of the converted EU marketing authorisation must submit to the licensing authority—

(i) the application for the variation; and

(ii) (subject to paragraph 13) the baseline data; and

(b) the licensing authority must consider the application in accordance with Schedule 10A.

(8) In this paragraph and paragraph 12, “minor variation of Type IA”, “minor variation of Type IB”, “major variation of Type II” and “extension” have the meanings given in paragraph 1 of Schedule 10A.

Variations of converted EU marketing authorisations submitted to EMA after IP completion day but before the data submission date

12

(1) This paragraph applies where a holder of a converted EU marketing authorisation—

(a) notifies the EMA of, or applies to the EMA for, a variation of the EU marketing authorisation to which the converted EU marketing authorisation relates during the period beginning with IP completion day and ending on the day before the data submission date; and

(b) wishes the variation to be made in relation to the converted EU marketing authorisation.

(2) Where the variation is a minor variation of Type IA—

(a) the variation may be implemented in relation to the converted EU marketing authorisation at the same time as it may be implemented in relation to the EU marketing authorisation to which the converted EU marketing authorisation relates;

(b) the holder of the converted EU marketing authorisation must (subject to paragraph 13), include in the baseline data—

(i) a summary of the variation, and

(ii) if the notification has been rejected by the EMA, an indication of that fact; and

(c) the variation to the converted EU marketing authorisation is deemed to be accepted unless the licensing authority notifies the holder in writing within the period of 30 days beginning with the data submission date that the variation is rejected, in which case the holder must cease to apply the rejected variation immediately after receipt of the notification.

(3) Where the variation is a minor variation of Type IB, a major variation of Type II or an extension which has not been rejected by the EMA—

(a) the holder of the converted EU marketing authorisation must submit to the licensing authority—

(i) the notification of, or application for, the variation, and

(ii) (subject to paragraph 13) the baseline data; and

(b) the licensing authority must consider the application in accordance with Schedule 10A.

Variations of converted EU marketing authorisations sought in advance of the data submission date

13

(1) If a holder of a converted EU marketing authorisation wishes the licensing authority to consider a notification of, or an application for, a variation to the authorisation before the data submission date, the holder must—

(a) submit the notification or application to the licensing authority; and

(b) unless sub-paragraph (2) applies, provide to the licensing authority at the same time such information concerning the product to which the converted EU marketing authorisation relates as may be specified in writing by the licensing authority for this purpose and published on or before IP completion day.

(2) If a holder of a converted EU marketing authorisation wishes the licensing authority to consider a notification of, or an application for, a variation to the authorisation before the data submission date but does not provide the information described in sub-paragraph (1)(b) with the notification or application, the licensing authority may agree to consider the notification or application if it is satisfied that—

(a) the variation may be necessary on urgent safety grounds;

(b) the variation may be necessary in order to maintain supplies of a particular medicinal product to patients in the United Kingdom; or

(c) there are other good reasons for considering the variation in advance of the submission of the information described in sub-paragraph (1).

(3) Where the licensing authority considers a notification of, or an application for, a variation in advance of the data submission date in accordance with this paragraph, the references in paragraphs 11(2)(c), (3)(c) and (5)(c)(ii) and 12(2)(c) to the data submission date are to be read as references to the date on which—

(a) the notification of, or the application for, the variation is submitted to the licensing authority in accordance with sub-paragraph (1); or

(b) the licensing authority notifies the holder that it will consider the notification or application, in accordance with sub-paragraph (2), without the information referred to in sub-paragraph (2)(b).

Applications for renewals of converted EU marketing authorisations made before IP completion day

14

(1) This paragraph applies where a holder of a converted EU marketing authorisation has, before IP completion day, made an application to the EMA for renewal of the EU marketing authorisation in accordance with Article 14 of Regulation (EC) No 726/2004 but no final decision has been made in relation to that application by the European Commission before IP completion day.

(2) Where this paragraph applies—

(a) the holder of the converted EU marketing authorisation must (subject to paragraph 18) submit the application for renewal to the licensing authority with the baseline data; and

(b) the licensing authority must—

(i) where before IP completion day the Committee for Medicinal Products for Human Use has given a positive final opinion in relation to the application with which the United Kingdom concurred, treat the renewal application as accepted for the purposes of regulation 66 (application for renewal of authorisation), or

(ii) where before IP completion day the Committee for Medicinal Products for Human Use has not given any opinion or has given a negative final opinion in relation to the application, or where a positive final opinion has been given but the United Kingdom recorded a divergent opinion, treat the application as an application made in relation to the converted EU marketing authorisation under regulation 66 and consider the application in accordance with that regulation.

Applications for renewals of conditional marketing authorisations made before IP completion day

15

(1) This paragraph applies where before IP completion day—

(a) a holder of a converted EU marketing authorisation which was granted as a conditional marketing authorisation within the meaning of Article 1 of Regulation (EC) No 507/2006 has made an application to the EMA for renewal of the authorisation in accordance with Article 6 of that Regulation; but

(b) no final decision has been made in relation to that application by the European Commission.

(2) Where this paragraph applies—

(a) the holder of the converted EU marketing authorisation must (subject to paragraph 18) submit the application for renewal to the licensing authority with the baseline data; and

(b) the licensing authority must—

(i) where before IP completion day the Committee for Medicinal Products for Human use has given a positive final opinion in relation to the application with which the United Kingdom concurred, treat the renewal application as accepted for the purposes of regulation 66B, or

(ii) where before IP completion day the Committee for Medicinal Products for Human Use has not given any opinion or has given a negative final opinion in relation to the application, or where a positive final opinion has been given but the United Kingdom recorded a divergent opinion, treat the application as an application made in relation to the converted EU marketing authorisation under regulation 66B (renewal of conditional marketing authorisation) and consider the application in accordance with that regulation.

Applications for renewals of converted EU marketing authorisations made after IP completion day

16

(1) This paragraph applies where a holder of a converted EU marketing authorisation is due to make an application for renewal of the authorisation in accordance with regulation 66 (application for renewal of authorisation) during the period of one year beginning with IP completion day.

(2) Where this paragraph applies—

(a) the holder of the converted EU marketing authorisation must (subject to paragraph 18) submit the baseline data so that it is received by the licensing authority at the same time as the application for renewal is made;

(b) the licensing authority must consider the renewal application in accordance with regulation 66; and

(c) the converted EU marketing authorisation remains in force until the licensing authority notifies the holder of its decision on the renewal application.

Applications for renewals of conditional marketing authorisations made after IP completion day

17

(1) This paragraph applies where the holder of a converted EU marketing authorisation which was granted as a conditional marketing authorisation within the meaning of Article 1 of Regulation (EC) No 507/2006 is due to make an application for renewal of the authorisation in accordance with regulation 66B during the period beginning with IP completion day and ending on the data submission date.

(2) Where this paragraph applies—

(a) the holder of the converted EU marketing authorisation must (subject to paragraph 18) submit the baseline data so that it is received by the licensing authority at the same time as the application for renewal is made;

(b) the licensing authority must consider the renewal application in accordance with regulation 66B (renewal of conditional marketing authorisation); and

(c) the authorisation remains in force until the licensing authority notifies the holder of its decision on the renewal application.

Renewals of converted EU marketing authorisations sought in advance of the data submission date

18

(1) If a holder of a converted EU marketing authorisation submits an application for renewal in accordance with regulation 66 or 66B before the data submission date, it must, unless sub-paragraph (2) applies, provide to the licensing authority with the application such information concerning the product to which the converted EU marketing authorisation relates as may be specified in writing by the licensing authority for this purpose and published on or before IP completion day.

(2) If a holder of a converted EU marketing authorisation wishes the licensing authority to consider a renewal application before the data submission date but does not provide the information described in sub-paragraph (1) with the application, the licensing authority may agree to consider the application if it is satisfied that—

(a) the renewal may be necessary on urgent safety grounds;

(b) the renewal may be necessary in order to maintain supplies of a particular medicinal product to patients in the United Kingdom; or

Article 61(3) notifications made before IP completion day in relation to converted EU marketing authorisations

19

(1) This paragraph applies where, before IP completion day—

(a) a holder of a converted EU marketing authorisation has, in accordance with Article 61(3) of the 2001 Directive, notified the EMA of a proposed change to an aspect of the labelling or the package leaflet of the EU marketing authorisation to which the converted EU marketing authorisation relates; but

(b) the period of 90 days referred to in Article 61(3) has not elapsed and the EMA has not objected to the proposed change.

(2) Where this paragraph applies, and where the holder wishes the proposed change to apply in relation to the converted EU marketing authorisation—

(a) the holder may put the change into effect in relation to the converted EU marketing authorisation at the same time as it may be put into effect in relation to the EU marketing authorisation;

(b) the holder must (subject to paragraph 21) include with the baseline data—

(i) a copy of the notification, and

(ii) an indication of whether the EMA has opposed the proposed change; and

(c) the proposed change to the labelling or the package leaflet of the converted EU marketing authorisation is deemed to be accepted unless the licensing authority notifies the holder in writing within the period of 30 days beginning with the data submission date that the proposed change is opposed, in which case the holder must cease to apply the opposed change immediately after receipt of the notification.

Article 61(3) notifications made in relation to converted EU marketing authorisations after IP completion day but before the data submission date

20

(1) This paragraph applies where, during the period beginning with IP completion day and ending on the day before the data submission date, a holder of a converted EU marketing authorisation notifies the EMA in accordance with Article 61(3) of the 2001 Directive of a proposed change to an aspect of the labelling or the package leaflet of the EU marketing authorisation to which the converted EU marketing authorisation relates.

(2) Where this paragraph applies, and where the holder wishes the proposed change to apply in relation to the converted EU marketing authorisation—

(a) the holder of the converted EU marketing authorisation may put the change into effect at the same time as it may be put into effect in relation to the EU marketing authorisation;

(b) the holder must (subject to paragraph 21) include with the baseline data—

(i) a copy of the notification, and

(ii) an indication of whether the EMA has opposed the proposed change; and

(c) the proposed change to the labelling or the package leaflet of the converted EU marketing authorisation is deemed to be accepted unless the licensing authority notifies the holder in writing within the period of 30 days beginning with the data submission date that the proposed change is opposed, in which case the holder must cease to apply the opposed change immediately after receipt of the notification.

Article 61(3) notifications sought in advance of the data submission date

21

(1) If a holder of a converted EU marketing authorisation wishes to notify the licensing authority of a proposed change to an aspect of the labelling or the package leaflet of the EU marketing authorisation to which the converted EU marketing authorisation relates in advance of the data submission date, the holder must—

(a) submit the notification of the proposed change to the licensing authority; and

(b) unless sub-paragraph (2) applies, at the same time provide the licensing authority with such information concerning the product to which the converted EU marketing authorisation relates as may be specified in writing by the licensing authority for this purpose and published on or before IP completion day.

(2) If a holder of a converted EU marketing authorisation wishes the licensing authority to consider a proposed change before the data submission date but does not provide the information described in sub-paragraph (1)(b) with the notification, the licensing authority may agree to consider the notification if it is satisfied that—

(a) the proposed change may be necessary on urgent safety grounds;

(b) the proposed change may be necessary in order to maintain supplies of a particular medicinal product to patients in the United Kingdom; or

(3) Where the licensing authority considers a proposed change in accordance with this paragraph, the references in paragraph 19(2)(c) and 20(2)(c) to the data submission date are to be read as references to the date on which—

(a) the proposed change is notified to the licensing authority in accordance with sub-paragraph (1); or

(b) the licensing authority notifies the holder that it will consider the notification, in accordance with sub-paragraph (2), without the information referred to in sub-paragraph (1)(b).

Place of establishment for converted EU marketing authorisation holder established in EEA state before IP completion day

22

(1) Subject to sub-paragraph (2), a person who—

(a) holds a converted EU marketing authorisation on IP completion day (whether or not it is suspended); and

(b) was, immediately before IP completion day, established in an EEA State, and remains established there on and after IP completion day,

is to be treated, for the transitional period, as satisfying the requirements of regulation 49(3) or 66(2) (as the case may be), notwithstanding the amendments made to those provisions by the EU Exit Regulations.

(2) But sub-paragraph (1) continues to apply to a person after the end of the specified period only if the person has, before the end of that period, notified the licensing authority in writing of—

(a) a named individual who resides and operates in the United Kingdom who the licensing authority may contact in respect of any matter relating to the converted EU marketing authorisation during the transitional period; and

(b) that individual's address, telephone number and email address.

(3) In this paragraph—

“the specified period” means 4 weeks beginning with IP completion day; and

“the transitional period” means the period of 24 months beginning with IP completion day.

Temporary exemption as to packaging requirements for converted EU marketing authorisations

23

(1) A holder of a converted EU marketing authorisation does not commit an offence under regulation 268 during the period of 36 months beginning with IP completion day to the extent that—

(a) the packaging and package leaflet do not comply with the requirements of Part 13 by reason only of the fact that the outer or immediate packaging, or the package leaflet, do not include the correct information as to—

(i) the name and address of the holder of the UK marketing authorisation, or, where applicable, the name of the holder's representative,

(ii) the number of the UK marketing authorisation, or

(iii) the name and address of the manufacturer of the product; and

(b) the outer and immediate packaging, or the package leaflet, do not include the correct information specified in paragraph (a)(i) to (iii) solely because—

(i) the number of the marketing authorisation is the number of the EU marketing authorisation to which the converted EU marketing authorisation relates, or

(ii) the UK marketing authorisation holder has established itself in the United Kingdom before the end of the period of 24 months beginning with IP completion day in order to comply with regulation 49(3), and the information specified in paragraph (a)(i) or (iii) is no longer correct as a consequence of that establishment in the United Kingdom.

(2) Sub-paragraph (1) only applies if—

(a) the packaging and package leaflet met the requirements of Part 13 as to the matters specified in sub-paragraph (1)(a)(i) to (iii) immediately before IP completion day; and

(b) the holder of the converted EU marketing authorisation, having been notified of the number of the UK marketing authorisation and having established itself in the United Kingdom, does not otherwise need to make any changes to the outer or immediate packaging, or the package leaflet, during the period referred to in sub-paragraph (1).

Referrals made under Article 20 of Regulation (EC) No 726/2004 that have not concluded or been implemented before IP completion day

24

(1) Sub-paragraph (2) applies where—

(a) the European Commission has requested the opinion of the EMA in accordance with Article 20(2) of Regulation (EC) No 726/2004 in relation to a specified matter; but

(b) no final decision has been adopted by the European Commission in accordance with Article 20(3) of that Regulation immediately before IP completion day.

(2) Where this sub-paragraph applies, the licensing authority must make a decision in respect of the specified matter in accordance with regulation 68 (revocation, variation and suspension of UK marketing authorisation) as soon as reasonably practicable.

(3) In making a decision under regulation 68 in accordance with sub-paragraph (2), the licensing authority must have regard to—

(a) any relevant information obtained by it before IP completion day in relation to the specified matter as a consequence of its involvement in the procedure under Article 20 of Regulation (EC) No 726/2004;

(b) any relevant decision made, or agreement reached, before IP completion day, where the United Kingdom participated as a member State in the making of that decision or agreement, under any procedure provided for in the Council Decision of 28 June 1999 laying down the procedure for the exercise of implementing powers conferred on the Commission; and

(4) Sub-paragraph (5) applies if the licensing authority is making a decision under regulation 68 in accordance with sub-paragraph (2) in a case where the Committee for Medicinal Products for Human Use has given a final opinion in relation to the specified matter.

(5) Where this sub-paragraph applies, the licensing authority may treat the opinion as if it were the opinion of the appropriate committee for the purposes of paragraph 5 of Schedule 11.

(6) Sub-paragraph (7) applies where—

(a) the European Commission has requested the opinion of the EMA in accordance with Article 20(2) of Regulation (EC) No 726/2004 in relation to a specified matter;

(b) a final decision has been adopted by the European Commission in accordance with Article 20(3) of that Regulation immediately before IP completion day; but

(c) the necessary steps to give effect to the decision referred to in paragraph (b) have not been taken before IP completion day.

(7) Where this sub-paragraph applies, the licensing authority must, where a Commission decision or opinion requires steps to be taken in respect of an EU marketing authorisation that is a converted EU marketing authorisation, take the steps necessary as a result of the decision or opinion to suspend, revoke or vary a converted EU marketing authorisation as soon as reasonably practicable.

(8) In this paragraph, “specified matter” means a matter in relation to which the opinion of the EMA has been requested by the European Commission under Article 20(2) of Regulation (EC) No 726/2004 before IP completion day that might result in the suspension, revocation or variation of an EU marketing authorisation which is a converted EU marketing authorisation.

Enforcement

25

If a holder of a converted EU marketing authorisation fails to comply with an obligation imposed on the holder by or under this Part, the licensing authority may suspend the authorisation until the holder complies with the obligation.

PART 4 — Transitional provision in respect of UK marketing authorisations, parallel import licences and parallel distribution notices

Status of certain UK marketing authorisations granted before IP completion day

26ZA

(1) This paragraph applies in relation to a UK marketing authorisation granted by the licensing authority under Chapter 4 of Title III to the 2001 Directive that was in force immediately before IP completion day.

(2) A UK marketing authorisation to which this paragraph applies—

(a) has effect on and after IP completion day as a UKMA(UK) granted under regulation 49(1) of these Regulations; and

(b) is treated as including a statement that it is in force in the whole United Kingdom for the purposes of regulation 49(1C).

Place of establishment for UK marketing authorisation holder or parallel import licence holder established in an EEA State before IP completion day

26

(1) Subject to sub-paragraphs (2) and (3), any person—

(a) who—

(i) holds a UK marketing authorisation immediately before IP completion day which remains in force on IP completion day (whether or not it is suspended),

(ii) holds a parallel import licence immediately before IP completion day which remains in force on IP completion day (whether or not it is suspended),

(iii) has made an application for, or to renew, a UK marketing authorisation or parallel import licence before IP completion day, which has not been determined before that date,

(iv) makes such an application on or after IP completion day but before the end of the transitional period; or

(v) is deemed to hold a parallel import licence under paragraph 28(2); and

(b) who was, immediately before IP completion day, established in an EEA State and remains established there on and after IP completion day,

is to be treated, for the transitional period, as satisfying the requirements of regulation 49(3), 66(2) or 66A(2) (as the case may be), notwithstanding the amendments made to those provisions by the EU Exit Regulations.

(2) But sub-paragraph (1) continues to apply to a person where the UK marketing authorisation or parallel import licence authorises sale or supply of the medicinal product in Great Britain only if the person has notified the licensing authority in writing of—

(a) a named individual who resides and operates in the United Kingdom who the licensing authority may contact in respect of any matter relating to the UK marketing authorisation or parallel import licence, or application for a UK marketing authorisation or parallel import licence (as the case may be), during the transitional period; and

(b) that individual's address, telephone number and email address.

(3) A person must notify the licensing authority under sub-paragraph (2)—

(a) where sub-paragraph (1)(a)(i) to (iii) applies, within the period of 4 weeks beginning with IP completion day; or

(b) where sub-paragraph (1)(a)(iv) applies, at the time of making the application.

(4) This paragraph does not apply to a UK marketing authorisation that is a converted EU marketing authorisation within the meaning of paragraph 6.

(5) In this paragraph “the transitional period” means the period of 24 months beginning with IP completion day.

Temporary exemption as to packaging requirements: change of place of establishment

27

(1) Subject to sub-paragraph (2), a person to whom paragraph 26 applies does not commit an offence under regulation 268 (offence relating to packaging and package leaflets in Great Britain: holder of authorisation etc) during the transitional period to the extent that—

(a) the packaging and package leaflet do not comply with the requirements of Part 13 (packaging and leaflets) by reason only of the fact that the outer or immediate packaging, or the package leaflet (as the case may be), do not include the correct information as to—

(i) the name and address of the holder of the UK marketing authorisation, or, where applicable, the name of that holder's representative,

(ii) the number of the UK marketing authorisation, or

(iii) the name and address of the manufacturer of the product; and

(b) the outer and immediate packaging, or the package leaflet, do not include the correct information specified in paragraph (a)(i) to (iii) solely because—

(i) the UK marketing authorisation holder has established itself in the United Kingdom before the end of the period of 24 months beginning with IP completion day in order to comply with regulation 49(3), and

(ii) the information specified in paragraph (a)(i) to (iii) is no longer correct as a consequence of that establishment in the United Kingdom.

(2) Sub-paragraph (1) only applies if—

(a) the packaging and package leaflet met the requirements of Part 13 as to the matters specified in paragraph (1)(a)(i) to (iii) immediately before IP completion day; and

(b) the UK marketing authorisation holder, having established itself in the United Kingdom, does not otherwise need to make any changes to the outer or immediate packaging, or the package leaflet, as the case may be, during the transitional period.

(3) In this paragraph “the transitional period” means the period of 36 months beginning with IP completion day.

Status of parallel import licences granted before IP completion day

27A

(1) This paragraph applies in relation to a parallel import licence granted by the licensing authority that was in force immediately before IP completion day.

(2) A parallel import licence to which this paragraph applies—

(a) has effect on and after IP completion day as a parallel import licence in force in the whole United Kingdom granted under regulation 49(1) of these Regulations; and

(b) is treated as including a statement that it is in force in the whole United Kingdom for the purposes of regulation 49(1C).

Conversion of parallel distribution notices in to parallel import licences

28

(1) Sub-paragraph (2) applies where—

(a) a person holds a parallel distribution notice, issued by the EMA, for a medicinal product in respect of which there is an EU marketing authorisation;

(b) that distribution notice, and that EU marketing authorisation, are in force immediately before IP completion day; and

(c) that parallel distribution notice specifies the United Kingdom as a member state of destination in respect of that medicinal product.

(2) Subject to sub-paragraph (3), a person who falls within sub-paragraph (1) is deemed, on and after IP completion day, to have a parallel import licence granted under Part 5, in force in Great Britain only, in respect of the medicinal product specified in the parallel distribution notice.

(3) A person who falls within sub-paragraph (1) continues to hold a parallel import licence pursuant to sub-paragraph (2) only if that person notifies the licensing authority—

(a) before the end of the period of 21 days beginning with IP completion day, of each medicinal product, and each country from which it is intended to import that product on or after IP completion day; and

(b) of any other information that the licensing authority requests, within such time period as the licensing authority may specify.

(4) The licensing authority must as soon as reasonably practicable after receipt of the information specified in sub-paragraph (3), issue a parallel import licence to the holder of the parallel distribution notice.

Inclusion of the batch testing condition in relevant UK marketing authorisations, and batch testing of biological medicinal products in the EEA before IP completion day (regulation 60A)

29

(1) Sub-paragraph (2) applies where—

(a) a marketing authorisation was in force before IP completion day,

(b) that authorisation is in force as a UK marketing authorisation on IP completion day (whether or not it is suspended); and

(c) that authorisation is for a medicinal product of a type that is specified in regulation 60A(2)(a) to (e) (condition as to the submitting of samples and other information to the appropriate authority).

(2) Where this sub-paragraph applies, the UK marketing authorisation is deemed to include the batch testing condition on and after IP completion day.

(3) Sub-paragraph (4) applies where a holder of a UK marketing authorisation has, before IP completion day, submitted to a competent authority of an EEA State samples for testing from a batch of a medicinal product (“the relevant batch”) that—

(a) is the subject of that authorisation; and

(b) is of a type specified in regulation 60A(2)(a) to (e).

(4) Where this sub-paragraph applies, the holder of the UK marketing authorisation is deemed to have satisfied the batch testing condition in respect of the relevant batch if, before IP completion day—

(a) the competent authority of that EEA State examines the sample from the relevant batch; and

(b) that authority declared it to be in conformity with the approved specifications (within the meaning of Article 114 of the 2001 Directive) before IP completion day.

(5) The appropriate authority—

(a) must include each EEA State on the list it publishes under regulation 60A(5) on IP completion day; and

(b) must not, before the end of the transitional period, exercise its powers under regulation 60A(8) to remove an EEA State from the list it publishes under regulation 60A(5).

(6) For the purposes of regulation 60A(9), the appropriate authority must, on IP completion day—

(a) include Switzerland and Israel in the list it publishes under that paragraph; and

(b) include in respect of those countries any conditions or restrictions in the arrangement with those countries that affect the applicability of the batch testing exemption.

(7) In this paragraph—

(a) “the transitional period” means the period of 24 months beginning with IP completion day; and

(b) “the batch testing condition” and “the batch testing exemption” have the same meaning as in regulation 60A.

(8) This paragraph, with the exception of sub-paragraphs (3) and (4), applies equally to a medicinal product imported into the United Kingdom pursuant to a parallel import licence and accordingly any reference in this paragraph (other than in this sub-paragraph) to—

(a) a marketing authorisation or a UK marketing authorisation is to be read as a reference to a parallel import licence for a medicinal product, and

(b) the holder of a UK marketing authorisation is to be read as a reference to the holder of a parallel import licence.

Application of the batch testing requirement to relevant EU marketing authorisations, and batch testing of biological medicinal products in the EEA before IP completion day (regulation 60B)

29A

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Existing data and marketing exclusivity and global marketing authorisations

30

(1) Sub-paragraph (2) applies in relation to a UK marketing authorisation which, immediately before IP completion day, is part of a global marketing authorisation with one or more EU marketing authorisations or marketing authorisations granted by the competent authority of an EEA state.

(2) Where this sub-paragraph applies, the provisions of regulation 48(5) (definitions for Part 5), in so far as they describe a global marketing authorisation by reference to UK marketing authorisations only, do not affect the periods of data and marketing exclusivity to which the holder of a UK marketing authorisation to which this paragraph applies is entitled immediately before IP completion day.

Applications for EU marketing authorisations made before IP completion day

31

(1) Sub-paragraph (2) applies where, before IP completion day—

(a) an application has been made to the EMA for an EU marketing authorisation; but

(b) no final decision has been made by the European Commission in relation to the grant of an EU marketing authorisation under Article 10 of Regulation (EC) No 726/2004.

(2) Where this sub-paragraph applies, the applicant may apply to the licensing authority for the grant of a UK marketing authorisation by submitting to the licensing authority—

(a) a copy of the application for the EU marketing authorisation; and

(b) if requested by the licensing authority, such material or information that the licensing authority reasonably considers necessary for dealing with the application.

(3) Sub-paragraph (4) applies where, before IP completion day and in relation to an application to which sub-paragraph (2) applies, a final opinion favourable to the granting of an EU marketing authorisation has been given by the Committee for Medicinal Products for Human Use and the United Kingdom concurred with that opinion.

(4) Where this sub-paragraph applies, the licensing authority must grant a UK marketing authorisation in response to an application as described in sub-paragraph (2) as soon as reasonably practicable after it is received.

(5) Sub-paragraph (6) applies where before IP completion day, in relation to an application to which sub-paragraph (2) applies—

(a) no final opinion favourable to the granting of an EU marketing authorisation has been given by the Committee for Medicinal Products for Human Use; or

(b) such an opinion has been given but the United Kingdom recorded a divergent opinion.

(6) Where this sub-paragraph applies, the licensing authority must consider an application made under sub-paragraph (2) in accordance with Part 5 of these Regulations (marketing authorisations).

Place of establishment for UK marketing authorisation holder established in EEA state before IP completion day (pre-exit EU marketing authorisation applications)

32

(1) Subject to sub-paragraph (2), a person—

(a) who applied to the EMA for an EU marketing authorisation before IP completion day;

(b) to whom the licensing authority grants a UK marketing authorisation on or after IP completion day in response to that application in accordance with paragraph 31; and

(c) who was, immediately before IP completion day, established in an EEA State, and remains established there on and after IP completion day,

is to be treated, for the transitional period, as satisfying the requirements of regulation 49(3), notwithstanding the amendments made to those provisions by the EU Exit Regulations.

(2) Sub-paragraph (1) applies to a person only if, when submitting a copy of the application for the EU marketing authorisation to the licensing authority in accordance with paragraph 31, the person notifies the licensing authority in writing of—

(a) a named individual who resides and operates in the United Kingdom whom the licensing authority may contact in respect of any matter relating to the UK marketing authorisation during the transitional period; and

(b) that individual's address, telephone number and email address.

(3) In this paragraph, “the transitional period” means the period which beginning with the date on which the licensing authority grants a UK marketing authorisation as described in paragraph 31(4) and ending 24 months after IP completion day.

Packaging in relation to UK marketing authorisations granted in response to application for EU marketing authorisation made before IP completion day

33

(1) Subject to sub-paragraph (2), a person to whom paragraph 32(1) applies does not commit an offence under regulation 268 (offence relating to packaging and package leaflets in Great Britain: holder of authorisation etc) during the transitional period to the extent that—

(a) the packaging and package leaflet do not comply with the requirements of Part 13 (packaging and leaflets) by reason only of the fact that the outer or immediate packaging, or the package leaflet, do not include the correct information as to—

(i) the name and address of the holder of the marketing authorisation, or, where applicable, the name of the holder's representative,

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