S.I. No. 43/1996 - Medical Preparations (Licensing and Sale) Regulations, 1996

S.I. No. 43 of 1996.

MEDICAL PREPARATIONS (LICENSING AND SALE) REGULATIONS, 1996.

In exercise of the powers conferred on the Minister for Health by Section 32 of the Irish Medicines Board Act, 1995 (No. 29 of 1995), which said powers are delegated to me by the Health (Delegation of Ministerial Functions) Order, 1996 ( S.I. No. 24 of 1996 ), I, BRIAN O'SHEA, Minister of State at the Department of Health, hereby make the following Regulations:—

1 Citation.

1.

1. These Regulations may be cited as the Medical Preparations (Licensing and Sale) Regulations, 1996.

2 Interpretations.

2.

2. (1) In these Regulations—

"the Act" means the Irish Medicines Board Act, 1995 ,

"the Board" means the Irish Medicines Board,

"certificate of registration" means a certificate issued under Article 8,

"homoeopathic medical preparation" means any medicinal product prepared from preparations, substances or compositions called homoeopathic stocks in accordance with a homoeopathic manufacturing procedure described in the European Pharmacopoeia or, in the absence of a manufacturing procedure for homoeopathic medical preparations in that pharmacopoeia, in accordance with a homoeopathic manufacturing procedure in any pharmacopoeia in official use in a Member State of the European Communities,

"import" includes procure the importation, and cognate words shall be construed accordingly,

"the Minister" means the Minister for Health,

"manufacture" includes,

— total and partial manufacture,

— the various processes of dividing up, packaging or presentation,

— assembling, compounding, filling, formulation, labelling, packaging, processing, or and

— the importation of a medical preparation from a country other than a Member State of the European Communities,

"pharmacist" means a registered pharmaceutical chemist or a registered dispensing chemist and druggist,

"product authorisation" means a licence granted or renewed by the Board in accordance with Article 7 of these regulations,

"registered dentist" means a person registered in the register established under the Dentists Act, 1928 (No. 25 of 1928),

"registered dispensing chemist and druggist" means a person registered in the register of dispensing chemists and druggists established under the Pharmacy Act, 1951 (No. 30 of 1951),

"registered medical practitioner" means a person registered in the register established under the Medical Practitioners Act, 1978 (No. 4 of 1978),

"registered pharmaceutical chemist" means a person registered in the register of pharmaceutical chemists for Ireland established under the Pharmacy Act (Ireland), 1875,

"retail sale" means sale to a person buying otherwise than for the purpose of resale,

"sale by wholesale" means sale or supply for the purposes of sale in the course of a business or for administration to patients in the course of a professional practice and cognate words shall be construed accordingly,

"sell" includes distribute or offer or keep for sale or distribution or procure the sale or distribution, and cognate words shall be construed accordingly.

• (2) In these Regulations any reference to an article or Schedule shall be construed as a reference to an article contained in these Regulations or, as the case may be, to a Schedule thereto, any reference in an article to a sub-article shall be construed as a reference to a sub-article of that article and any reference in a Schedule to a paragraph shall be construed as a reference to a paragraph of that Schedule.

• (3) In these Regulations, except in article 5, every reference to a product authorisation shall include reference to a certificate of registration issued under article 8.

3 Requirement that medical preparations be licensed.

3.

3. (1) Subject to article 4, a person shall not, in the course of a business carried on by him

( a ) import, place on the market or otherwise sell any medical preparation, or

( b ) procure the manufacture for sale of any medical preparation,

except such preparation is the subject of a licence granted or renewed by the Board under these Regulations, hereinafter referred to as a "product authorisation" or an authorisation granted or renewed in accordance with Council Regulation No. (EEC) 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medical preparations for human and veterinary use and establishing a European Agency for the Evaluation of medical preparations (OJ No. L214 of 24 August 1993) (hereinafter referred to as a marketing authorisation) and such importation, placing on the market or sale is in accordance with the terms of such product authorisation or marketing authorisation as the case may be.

4 Exemptions from the requirement that medical preparations be licensed.

4.

4. The provisions of article 3 shall not apply as respects—

( a ) the sale of a medical preparation by a person lawfully keeping open shop for the dispensing or compounding of medical prescriptions or for the sale of poisons under the Pharmacy Acts, 1875 to 1977 where such sale is carried out and the preparation is extemporaneously compounded by or under the supervision of a pharmacist for such particular sale,

( b ) the importation or sale of a medical preparation by or to the order of a registered medical practitioner or registered dentist for the treatment of a patient under his care,

( c ) the importation of a medical preparation by any person for his own personal use, not being an importation resulting directly from a mail order advertisement directed to members of the public,

( d ) the importation or sale of a medical preparation solely for the purpose of its being exported,

( e ) the manufacture or importation of a medical preparation which is intended for use in the conducting of a clinical trial, in accordance with a permission granted under section 4 of the Control of Clinical Trials Act, 1987 (No. 28 of 1987).

5 Applications and criteria of assessment for the grant of product authorisations.

5.

5. (1) An application for a product authorisation shall be made to the Board and shall be in such form and be accompanied by such information, documents, samples and other materials, as the Board may require in accordance with the provisions of Council Directive 65/65/EEC, as amended, together with the appropriate fee provided for under article 11.

• (2) In the examination and determination of an application for a product authorisation the Board shall take into consideration such criteria as appears to be relevant in the case of the application and, in particular, the information supplied by the applicant in relation to—

( a ) the safety and efficacy of the medical preparation to which the application relates and the purpose for which the medical preparation is intended by the applicant to be administered, and

( b ) the quality of the medical preparation.

6 Applicant other than manufacturer.

6.

6. (1) Where the applicant for a product authorisation is not the manufacturer of the medical preparation or where the medical preparation is to be imported into the State, the Board may require the applicant to furnish a written undertaking in a form approved by the Board and signed by or on behalf of the manufacturer of the preparation that in the event of the preparation authorisation being granted or renewed the manufacturer will comply with such conditions as may be specified in such undertaking and, in particular, that he will—

( a ) permit the inspection by or on behalf of the Board of the premises where the preparation is to be manufactured and of the operations to be carried out in the course of manufacture;

( b ) comply with any conditions relating to the manufacture of the preparation subject to which the authorisation is granted or renewed;

( c ) comply with any requirements imposed by or under the law of the country in which the preparation is to be manufactured.

7 Product authorisations.

7.

7. (1) The Board may grant or renew a product authorisation to any person who applies for such authorisation in accordance with Article 5.

• (2) A product authorisation granted under this article shall:—

( a ) incorporate a summary of product characteristics containing the information set out in Part I of the First Schedule to these Regulations, and

( b ) be subject

• (i) to the general conditions specified in Part II of the said First Schedule, and

• (ii) to the special conditions, if any, specified in the product authorisation,

• (3) Unless sooner revoked by the Board a product authorisation shall normally remain in force for a period of five years and may be renewed on application made by the holder thereof not later than three months before the date of expiry of the authorisation concerned.

8 Homoeopathic medical preparation.

8.

8. (1) The Board may grant or renew a certificate of registration in respect of any homoeopathic medical preparation which satisfies the conditions set out in sub-article (2) to any person who make application in writing for such certificate in accordance with Article 7 and for such purpose the information, documents, samples and other material required by the Board shall be as specified in the Third Schedule.

• (2) Subject to sub-article (3), the conditions to be met for the purpose of registration under sub-article (1) are that the homoeopathic medical preparation shall be such that—

• (i) it is intended to be administered orally or externally;

• (ii) no specific therapeutic indication appears on the labelling of the preparation or in any information relating thereto; and

• (iii) there is a sufficient degree of dilution to guarantee safety.

• (3) The homoeopathic medical preparation shall not be considered to have a sufficient degree of dilution to guarantee safety if—

• (i) in the case of a medical preparation containing an active principle the presence of which in an allopathic medical preparation would, by virtue of the Medical Preparations (Prescription and Control of Supply) Regulations, 1993 ( S.I. No. 69 of 1993 ), require the presentation of a prescription issued by a registered medical practitioner in order that the said preparation may be supplied, if it contains either more than one part per 10,000 of the mother tincture or more than one hundredth of the smallest dose of the said active principle as used in allopathy, or

• (ii) in any other case, if it contains more than one part per 10,000 of the mother tincture.

• (4) The registration referred to in sub-article (1) shall be subject to the conditions specified in the Fourth Schedule.

• (5) Unless sooner revoked by the Board, the aforementioned registration shall normally remain in force for a period of five years and may be renewed on application made by the holder thereof not later than three months before the date of expiry of the certificate concerned.

• (6)
• (i) The provisions of Articles 5, 6 and 9 shall apply to homoeopathic medical preparations to which this article relates as if the references in thosearticles to efficacy and therapeutic efficacy had been omitted.

• (ii) Sub-article (v) of Article 9 (1) (b) shall not apply to homoeopathic medical preparations to which this article applies.

9 Refusal of application for or revocation of product authorisation.

9.

9. (1) The Board may refuse an application for a product authorisation where—

• (a) the applicant fails to submit information, documents, samples or other materials in accordance with Article 5 (1), or

• (b) the Board is satisfied, following examination of such information, documents, samples or other materials that—

• (i) the information contained in or furnished in connection with the application is found to be incorrect in any material respect, or

• (ii) the preparation is harmful under normal conditions of use, or

• (iii) the therapeutic efficacy of the preparation is lacking or is insufficiently substantiated by the applicant, or

• (iv) the qualitative or quantitative composition of the preparation to which the application relates is not as declared by the applicant,

• (v) the labelling or the package leaflet do not comply with the provisions of Medical Preparations (Labelling and Package Leaflets) Regulations, 1993 ( S.I. No. 71 of 1993 ) or if they are not in accordance with the summary of product characteristics in respect of the medical preparation in question.

• (2) The Board may revoke or suspend a product authorisation with the written consent of the holder thereof, or where it is satisfied that—

• (a) the preparation to which the authorisation relates is harmful under normal conditions of use, or

• (b) the therapeutic efficacy of such preparation is lacking, or

• (c) the qualitative or quantitative composition of such preparation is not in accordance with the information declared by the holder, or

• (d) the controls on the preparation, or on any of its constituents, in the course of its manufacture as indicated in or in connection with the application or in compliance with any conditions subject to which the authorisation was granted or renewed have not been carried out, or

• (e) the requirements of the Medical Preparations (Licensing of Manufacture) Regulations, 1993, as amended, have not been complied with, or

• (f) the information contained in or furnished in connection with the application for the authorisation is incorrect in any material respect, or

• (g) any condition subject to which the authorisation was granted or renewed has not been complied with.

10 Exclusions from requirement of product authorisation.

10.

10. These Regulations shall not apply as respects—

• (a) any substance or preparation which is intended solely for use as an ingredient in the manufacture of a medical preparation, or

• (b) any medical preparation, consisting of a dried, crushed or comminuted herb or combination of herbs which is to the sold—

• (i) under a designation which specifies the herb or herbs and the process of preparation only and does not apply any other name to the preparation, and

• (ii) without any recommendation as to the use of the preparation as a medical preparation.

11 Fees.

11.

11. There shall be paid to the Board such fees in respect of matters provided for in these regulations as the Minister may, by regulation, provide for.

12 Enforcement.

12.

12. (1) The enforcement and execution of the provisions of these Regulations may be carried out by

• (a) officers of the Minister,

• (b) officers of the Board,

• (c) health boards and their officers,

• (d) in so far as persons involved in the retail sale of medical preparations are concerned, the Pharmaceutical Society of Ireland and its officers.

• (2) Subject to sub-article (3) any such officer as aforesaid (with in the case of an officer of the Minister, a written authorisation of the Minister, in the case of an officer of the Board, a written authorisation of the Board and in the case of an officer of a health board, a written authorisation of the board), may, at all reasonable times, for the purpose of ascertaining whether or not there is or has been a contravention of these Regulations—

• (a) enter premises of any class or description,

• (b) inspect any substance, preparation or article which is stored, kept or offered for sale at such premises,

• (c) require the production of and, if he thinks fit, take copies of any register, book, record, order, invoice or other document, and inspect and, if the officer thinks fit, take copies of any entry in any such book, record or other document at such premises, and

• (d) take (without payment) samples of any substance, preparation or article stored or offered or kept for sale at such premises for test, examination or analysis.

• (3) Sub-article (2) shall not apply as respects any of the following premises—

• (a) such part of any premises (not being a shop) as is used by a registered medical practitioner or registered dentist for carrying on his practice, or

• (b) a premises used only as a private dwelling.

• (4) So much of sub-article (2) as enables officers of the Pharmaceutical Society of Ireland to enter premises of any class or description shall not apply as respects any of the following premises—

• (a) a hospital, nursing home, clinic or similar institution;

• (b) the premises of a manufacturer of a medical preparation.

13 Certificate of analysis.

13.

13. (1) In any proceedings for an offence under section 32 of the Act in relation to these Regulations a certificate signed by—

• (a) the State Chemist, or

• (b) a public analyst appointed under section 10 of the Sale of Food and Drugs Act, 1875.

stating the result of any test, examination or analysis of a sample shall, with regard to that sample, be evidence for all purposes of such result.

• (2) The certificate referred to in sub-article (1) shall be in the form set out in the Second Schedule to these Regulations.

14 Transitional arrangements.

14.

14. (1) An authorisation granted or renewed pursuant to the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 to 1994 and in force immediately before the commencement of these Regulations shall continue in force until it expires or is sooner revoked and shall have effect as if it were a product authorisation granted or renewed under these Regulations.

• (2) An application made pursuant to the said Regulations which had not been determined prior to the commencement of these Regulations shall be treated as if it were an application for a product authorisation under these Regulations.

15 Revocation of previous Regulations.

15.

15. On the coming into operation of these Regulations the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 to 1994 shall be revoked.

16 Commencement.

16.

16. These regulations shall come into operation on the 19th day of February, 1996.

FIRST SCHEDULE

(Article 7)

PART I Information to be included in Summary of Product Characteristics

5.1 therapeutic indications,

5.2 contra-indications,

5.3 undesirable effects (frequency and seriousness),

5.4 special precautions for use,

5.5 use during pregnancy and lactation,

5.6 interaction with other medicaments and other forms of interaction,

5.7 posology and method of administration for adults and, where necessary, for children,

5.8 overdose (symptoms, emergency procedures, antidotes),

5.9 special warnings,

5.10 effects on ability to drive and to use machines.

6.1 incompatibilities (major),

6.2 shelf life, when necessary after reconstitution of the product or when the container is opened for the first time,

6.3 special precautions for storage,

6.4 nature and contents of container,

6.5 name or style and permanent address or registered place of business of the holder of the authorisation,

6.6 special precautions for disposal of unused preparations or waste materials derived from such preparations, if appropriate.

(Article 7)

PART II General Conditions Applicable to Authorisations

• (a) in the composition of the preparation, or of any of its constituents,

• (b) in the specification of the preparation or of any of its constituents,

• (c) in the methods of manufacture of the preparation or of any of its constituents,

• (d) in the methods and procedures described in the application for ensuring compliance with such specifications,

• (e) in the arrangements described in the application for storage of the preparation,

• (f) in the recommended uses, routes of administration or dosage schedules, or

• (g) in the method of retail sale, supply or sales promotion.

• (a) for obtaining materials for the purpose of the manufacture by him or on his behalf of any preparation to which the authorisation relates, and

• (b) for procuring the manufacture, importation, storage, sale or supply of any such preparation, and

• (c) for the tests to be carried out on any such preparation or on the materials used for its manufacture

and shall permit the person so authorised to take copies of, or to make extracts from, such records. The records shall be retained for a period of five years from the date on which the relevant batch of the preparation was released for sale or was imported by or on behalf of the authorisation holder.

• (a) to be harmful under normal conditions of use, or

• (b) to be lacking in therapeutic efficacy, or

• (c) not to be in accordance with the information contained in or furnished in connection with the application for such authorisation, or furnished in compliance with any of the conditions set out in this Schedule, as regards the qualitative or quantitative composition of the preparation, or

• (d) not to be in accordance with any conditions, other than those set out in this Schedule, which are specified in the authorisation, shall, if so directed by the Board, withhold from sale all batches of the preparation or such batch as may be specified by the Board, and so far as may reasonably be practicable, immediately recall all supplies of the preparation or of such batch of the preparation as has already been issued.

• (2) The authorisation holder shall comply with the conditions set out in sub-paragraph (1) where the controls on the preparation to which the authorisation relates, or on any of its constituents, in the course of its manufacture as indicated in or in connection with his application for the authorisation or in compliance with the conditions set out in this Schedule, have not been carried out.

• (i) furnish from such batch or batches as may be specified a sample of any preparation to which the authorisation relates for the purpose of test, examination or analysis, or

• (ii) furnish full particulars of the tests which have been applied to such batch or batches of such preparation as may be specified and the result of such tests.

• (a) that the preparation to which the authorisation relates is not sold unless it has been manufactured in the premises in respect of which any undertaking has been given pursuant to article 6.

• (b) that such preparation has been manufactured in such premises and in such circumstances as to comply with any conditions specified in such undertaking.

(Article 13)

SECOND SCHEDULE

Medical Preparations (Licensing and Sale) Regulations, 1996 ( S.I. No. 43 of 1996 ) Certificate stating results of test, examination or analysis This Certificate is issued by me, the undersigned, for the purpose of article 13 of the Medical Preparations (Licensing and Sale) Regulations, 1996 being^(1) __ I hereby certify that I received on the _ day of ____ 19 __ from^(2) ___ of ____ a sample of^(3) _____ for test, examination and analysis, which was undamaged, duly sealed and marked^(4) ___ I further certify that the said sample has been tested, examined and analysed by me or under my direction and that the results are as follows:—^(5) Results Signature ___ Date ____ ^(1) Here insert official title of analyst. (2) Here insert the name of the sampling officer or agent who submitted the sample for analysis. (3) Here insert the name or description of the substance or preparation. (4) Here insert the distinguishing mark on the sample and the date of sampling shown thereon. (5) Here insert the relevant results as appropriate.

(Article 8)

THIRD SCHEDULE

Information, Samples, Documents and other Materials required in Applications for Certificates of Registration for Homoeopathic Medical Preparations

( a ) the person responsible for placing the preparation on the market in Ireland; and

( b ) the manufacturer and the locations involved in the different stages of manufacture. Such shall include the manufacturers of the homoeopathic stock or stocks and the finished preparation;

(Article 8)

FOURTH SCHEDULE

Conditions Subject to which Homoeopathic Medical Preparations are Registered

( a ) in the composition of the preparation, or of any of its constituents,

( b ) in the specification of the preparation, or of any of its constituents,

( c ) in the methods of manufacture of the preparation, or of any of its constituents,

( d ) in the methods and procedures described in the application for ensuring compliance with such specifications,

( e ) in the arrangements described in the application for storage of the preparation,

( f ) in the route(s) of administration or in the dosage schedules, or

( g ) in the method of retail sale or supply.

( a ) for obtaining materials for the purpose of manufacture by him/her or on his/her behalf of any preparation to which the registration relates, and

( b ) for procuring the manufacture, importation, storage, sale or supply of any such preparation, and

( c ) for the tests to be carried out on any such preparation or on the materials used in its manufacture

and shall permit the person so authorised to take copies of, or to make extracts from, such records. The records shall be retained for a period of five years from the date on which the relevant batch of the preparation was released for sale.

( a ) to be harmful under normal conditions of use, or

( b ) not to be in accordance with the information contained in or furnished in connection with the application for such registration, or furnished in compliance with any of the conditions set out in this Schedule, as regards the qualitative or quantitative composition of the preparation,

shall, if so directed by the Board, withdraw from sale all batches of the preparation or such batch(es) as any be specified by the Board, and so far as may reasonably be practicable, immediately recall all supplies of the preparation or of such batch(es) of the preparation as have already been issued.

• (2) The registration holder shall comply with the conditions set out in sub-paragraph (1) where the controls on the preparation to which the registration relates, or on any of its constituents, in the course of its manufacture as indicated in or in connection with his application for the registration or in compliance with the conditions set out in this schedule, have not been carried out.

( a ) that the preparation to which the registration relates is not sold unless it has been manufactured in the premises in respect of which any undertaking has been given pursuant to article 6.

( b ) that such preparation has been manufactured in such premises and in such circumstances as to comply with any conditions specified in such undertaking.

Dated this 13th day of February, 1996.

BRIAN O'SHEA,

Minister of State at the Department of Health.

EXPLANATORY NOTE.

The purpose of these regulations is to bring together in one instrument the provisions of the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984-1994. The regulations provide for a licensing scheme for human medicines and related matters as required by Council Directive 65/65/EEC of 26 January 1965, as amended, (O.J. No. 22 of 9.2.65) and, in so far as homoeopathic medicines are concerned, Council Directive 92/72/EEC of 22 September 1992 (O.J. No. L297 of 13.10.92).

The regulations also provide that the authority to licence human medicines, heretofore exercised by the Minister for Health, shall be exercised by the Irish Medicines Board with effect from 19th February, 1996.