S.I. No. 142/1998:

MEDICINAL PRODUCTS (LICENSING AND SALE) REGULATIONS, 1998

MEDICINAL PRODUCTS (LICENSING AND SALE) REGULATIONS, 1998

The Minister for Health and Children, in exercise of the powers conferred on him by Section 32 of the Irish Medicines Board Act, 1995 (No. 29 of 1995), hereby makes the following Regulations:--

1. These Regulations may be cited as the Medicinal Products (Licensing and Sale) Regulations, 1998.

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 medicinal product" 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 medicinal products 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 and Children;

"manufacture" includes:

-- total and partial manufacture,

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

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

-- the importation of a medicinal product 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 and 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 7, every reference to a product authorisation shall include reference to a certificate of registration issued under article 8.

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 medicinal product, or

(b) procure the manufacture for sale of any medicinal product,

except such product 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 medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of medicinal products (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. The provisions of article 3 shall not apply as respects --

(a) the sale of a medicinal product 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 product is extemporaneously compounded by or under the supervision of a pharmacist for such particular sale;

(b) the importation or sale of a medicinal product 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 medicinal product 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 medicinal product solely for the purpose of its being exported;

(e) the manufacture or importation of a medicinal product 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. (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 Directives 65/65/EEC (O.J.No.22 of 9.2.65), 75/318/EEC (O.J.No.L147 of 9.6.75) and 75/319/EEC (O.J.No.L147 of 9.6.75), 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 appear 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 medicinal product to which the application relates and the purpose for which the medicinal product is intended by the applicant to be administered, and

(b) the quality of the medicinal product.

6. Where the applicant for a product authorisation is not the manufacturer of the medicinal product or where the medicinal product 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 product that in the event of the product 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 product 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 product 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 product is to be manufactured.

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. (1) The Board may grant or renew a certificate of registration in respect of any homoeopathic medicinal product which satisfies the conditions set out in sub-article (2) to any person who makes application in writing for such certificate 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 medicinal product 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 product or in any information relating thereto; and

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

(3) The homoeopathic medicinal product shall not be considered to have a sufficient degree of dilution to guarantee safety if -

(i) in the case of a medicinal product containing an active principle the presence of which in an allopathic medicinal product would, by virtue of the Medicinal Products (Prescription and Control of Supply) Regulations, 1996 (S.I. Nos. 256 and 309 of 1993), require the presentation of a prescription issued by a registered medical practitioner in order that the said product 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) The provisions of Articles 5 and 9 shall apply to homoeopathic medicinal products to which this article relates as if the references in those articles to efficacy and therapeutic efficacy had been omitted.

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, in the case of an application for a certificate of registration for a homoeopathic medicinal product, the third schedule hereof, 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 product is harmful under normal conditions of use, or

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

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

(v) the labelling or the package leaflet do not comply with the provisions of the Medical Preparations (Labelling and Package Leaflets) Regulations, 1993 and 1994 or are not in accordance with the summary of product characteristics in respect of the medicinal product 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 product to which the authorisation relates is harmful under normal conditions of use, or

(b) the therapeutic efficacy of the product is lacking, or

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

(d) the controls on the product, 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. These Regulations shall not apply as respects -

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

(b) any medicinal product, consisting of a dried, crushed or comminuted herb or combination of herbs which is to be 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 product, and

(ii) without any recommendation as to the use of the product as a medicinal product.

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. (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 medicinal products 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, in the case of an officer of a health board, a written authorisation of the board and in the case of an officer of the Pharmaceutical Society of Ireland, a written authorisation of the Society), 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, product or article which is stored, kept or offered for sale at such premises,

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

(d) take (without payment) samples of any substance, preparation, product 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 medicinal product.

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. (1) An authorisation granted or renewed pursuant to the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 to 1994 or the Medical Preparations (Licensing and Sale Regulations), 1996 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 under these Regulations.

15. The Medical Preparations (Licensing, and Sale) Regulations, 1996 are hereby revoked.

First Schedule

(Article 7)

Part I

Information To Be Included In Summary Of Product Characteristics

1. Name of the medicinal product.

2. Qualitative and quantitative composition in terms of the active ingredients and constituents of the excipient, knowledge of which is essential for proper administration of the medicinal product; the international non-proprietary names recommended by the World Health Organisation shall be used, where such names exist, or failing this, the usual common name or chemical description.

3. Pharmaceutical form.

4. Pharmacological properties and, in so far as this information is useful for therapeutic purposes, pharmacokinetic particulars.

5. Clinical particulars:

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. Pharmaceutical particulars:

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 products or waste materials derived from such products, if appropriate.

PART II

(Article 7)

General Conditions Applicable To Authorisations.

1. The authorisation holder shall report to the Board any change of name and/or address and any change of address at which there is carried on a business to which the authorisation relates.

2. The authorisation holder shall ensure that any product to which the authorisation relates is manufactured only in accordance with the methods set out in, or furnished in connection with, his application for the authorisation and that the specifications of the constituents and of the finished product are in accordance with the information contained in, or furnished in connection with the said application, except insofar as may otherwise be approved by the Board.

3. The authorisation holder shall not issue, or cause another person to issue, or consent to the issue of any advertisement or recommendation, relating to any product to which the authorisation relates, which contains particulars as to the uses, nature or effects of such product or warnings or precautions in use concerning such product, unless the terms of the advertisement or recommendation, insofar as they relate to such particulars, warnings, or precautions in use correspond to or differ only to an extent that is not material from those specified in the authorisation.

4. The authorisation holder shall inform the Board of any material change that has been made, or is proposed to be made in the particulars contained in or furnished in connection with the application, in relation to any product to which the authorisation relates, that is to say -

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

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

(c) in the methods of manufacture of the product 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 product,

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

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

5. The authorisation holder shall notify the Board of any change proposed to be made in the labelling or package leaflet relating to any medicinal product to which the authorisation relates. Any such change not connected with the summary of product characteristics, which have not been opposed by the Board within 90 days following the said notification shall be deemed to be approved by the Board and may be put into effect by the authorisation holder.

6. The authorisation holder shall inform the Board of any additional information received by him which may alter the validity of data provided in support of the application, or may further the understanding of the substance and its effects or may alter the directions for use of the medicinal product which is the subject of the authorisation.

7. The authorisation holder shall keep a record of reports of adverse effects associated with the use of the product to which the authorisation relates. The record shall be available for inspection by a person authorised by the Board who may take copies thereof. The authorisation holder shall furnish to the Board a copy of any such report of which he has a record or of which he is aware.

8. The authorisation holder shall keep available for inspection by a person authorised by the Board durable records of his arrangements -

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

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

(c) for the tests to be carried out on any such product 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 product was released for sale or was imported by or on behalf of the authorisation holder.

The authorisation holder shall keep such documents as will facilitate the withdrawal or recall from sale or supply of any product to which the authorisation relates.

10. (1) The authorisation holder, on being informed by the Board that any product to which the authorisation relates has been found -

(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 product, 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 product or such batch as may be specified by the Board, and so far as may reasonably be practicable, immediately recall all supplies of the product or of such batch of the product 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 product 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.

11. The authorisation holder shall notify the Board of any decision to withdraw from sale or supply any product to which the authorisation relates and shall state the reason for that decision.

12. The authorisation holder shall on request by the Board -

(i) furnish from such batch or batches as may be specified a sample of any product 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 product as may be specified and the result of such tests.

13. The authorisation holder shall, if requested by the Board, withhold from sale any batch or batches in respect of which a sample is, or particulars are, requested to be furnished under sub-paragraphs (i) and (ii) of paragraph 12 until a certificate authorising the sale of the batch or batches has been issued to him by the Board.

14. The authorisation holder shall ensure -

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

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

15. The authorisation holder shall in the event of the authorisation being revoked surrender it to the Board.

Second Schedule

(Article 13)

Third Schedule

(Article 8)

Information, Samples, Documents And Other Materials Required In Applications For Certificates Of Registration For Homeopathic Medicinal Products.

1. The name and permanent address of -

(a) the person responsible for placing the product 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 product.

2. Details of the scientific name or other name in a pharmacopoeia of the homoeopathic stock or stocks.

3. A statement of the various routes of administration, pharmaceutical forms and the degree of dilution to be registered.

4. A dossier describing how the homoeopathic stock or stocks is or are to be obtained and controlled and justifying its or their homoeopathic nature on the basis of an adequate bibliography.

5. A manufacturing and control file for each pharmaceutical form and a description of the method of dilution and potentisation.

6. A copy of the manufacturers licence held under the Medical Preparations (Licensing of Manufacture) Regulations, 1993 (as amended), or a corresponding manufacturing authorisation granted in another Member State of the European Communities in respect of the homoeopathic medicinal product concerned.

7. Copies of any registrations or authorisations obtained for the same homoeopathic medicinal product in another Member State of the European Communities.

8. One or more specimens or mock-ups of the sales presentation of the homoeopathic medicinal product to be registered.

9. Data concerning the stability of the homoeopathic medicinal product concerned.

Fourth Schedule

(Article 8)

Conditions Subject To Which Homoeopathic Medicinal Products Are Registered

1. The holder of the certificate of registration (hereinafter referred to as the registration holder) shall report to the Board any change in the name and address and in any address at which there is carried on a business to which the registration relates.

2. The registration holder shall ensure that any product to which the registration relates is manufactured only in accordance with the methods set out in, or furnished in connection with, his application for registration and that the specifications of the constituents and of the finished product are in accordance with the information contained in, or furnished in connection with, the said application except insofar as may otherwise be approved by the Board.

3. The registration holder shall inform the Board of any material change that has been made, or is proposed to be made in the particulars contained in or furnished in connection with his application, in relation to any product to which the registration relates, that is to say -

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

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

(c) in the methods of manufacture of the product, 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 product,

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

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

4. The registration holder shall keep a record of adverse effects associated with the use of the product to which the registration relates. The record shall be available for inspection by a person authorised by the Board who may take copies thereof. The registration holder shall furnish to the Board a copy of any such report of which he has a record or of which he is aware.

5. The registration holder shall keep available for inspection by a person authorised by the Board durable records of the arrangements -

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

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

(c) for the tests to be carried out on any such product 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 product was released for sale.

6. The registration holder shall keep such documents as will facilitate the withdrawal or recall from sale or supply of any product to which the registration relates.

7. (1) The registration holder, on being informed by the Board that any product to which the registration relates has been found -

(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 product,

shall, if so directed by the Board, withdraw from sale all batches of the product or such batche(s) as any be specified by the Board, and so far as may reasonably be practicable, immediately recall all supplies of the product or of such batche(s) of the product 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 product 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.

8. The registration holder shall notify the Board of any decision to withdraw from sale or supply any product to which the registration relates and shall state the reason for that decision.

9. The registration holder shall ensure -

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

10. The registration holder shall in the event of the registration being revoked surrender it to the Board.

GIVEN under the Official Seal of the Minister for Health and Children this 6th day of May, 1998.

Brian Cowen

Minister for Health and Children.

EXPLANATORY NOTE

These regulations replace the Medical Preparations (Licensing and Sale) Regulations, 1996. The Regulations provide for a licensing scheme for medicinal products for human use and related matters as required by Council Directives 65/65/EEC of 26 January 1965, (O.J. No. 22 of 9.2.65), 75/318/EEC (O.J. No. L147 of 9.6.75) and 75/319/EEC (O.J. No. L147 of 9.6.75) as amended, 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).