Medicinal Products (Control of Placing on the Market) Regulations, 2007

• Jurisdiction: Ireland
• Citation: IR SI 540/2007
• Year: 2007

ARRANGEMENTS OF REGULATIONS

PART 1

General Provisions

1. Citation.

2. Commencement.

3. Interpretation.

4. Scope of Regulations

5. Responsibility for functions under the EC Regulations and Directives.

PART 2

Authorisation and Certification for placing a Medicinal Product on the Market

6. Requirement for authorisation or certificate to place a medicinal product on the market.

7. Prohibition of marketing during period of data protection.

8. Immunity from liability in certain cases where an unauthorised medicinal product is used, or an authorised medicinal product is used for an unauthorized indication on the temporary authorisation of the Minister.

9. Application for the grant, renewal or variation of authorisations or certificates.

10. Consideration by the Board of applications in connection with authorisations and certificates, including their grant, refusal, renewal, variation and duration.

11. Authorisation of homeopathic medicinal products under national rules.

12. Classification of medicinal products.

13. Urgent safety restrictions.

14. Revocation, suspension, or variation of an authorisation or certificate or the suspension of the use or marketing of medicinal products.

PART 3

Obligations of Persons placing Medicinal Products on the Market

15. General obligations.

16. Labelling and package leaflets.

17. Pharmacovigilance.

18. Information on pharmacovigilance concerns for the general public.

19. Obligation to ensure that supplies continue to be available to meet the needs of patients.

PART 4

Amendment of Medicinal Products (Prescription and Control of Supply) Regulations 2003

20. Interpretation.

21. Medicinal products subject to prescription control.

22. Prescription status of certain medicinal products including those that are the subject of authorisations or certificates granted prior to the coming into force of these Regulations.

23. Exemptions in respect of the supply and administration of a medicinal product on the temporary authorisation of the Minister in certain emergency situations.

24. Restatement of Regulation 20A as it applies to the Seventh Schedule

PART 5

Transitional arrangements and revocations

25. Transitional provisions.

26. Revocation.

PART 6

27. Amendment of European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004.

28. Collective citation for Medicinal Products (Prescription and Control of Supply) Regulations, 2003 (as amended).

29. Collective citation for European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 (as amended).

SCHEDULE 1

Exemptions from the Authorisation and Certification requirements of Regulation 6

SCHEDULE 2

Procedural provisions relating to proposals to grant subject to carrying out of certain obligations, proposals to grant otherwise than in accordance with the application, proposals to refuse to grant or vary, proposals to make the authorisation or certificate conditional on the carrying out of certain obligations, and proposals to suspend, vary or revoke an authorisation or certificate

S.I. No. 540 of 2007

MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS 2007

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 31st July, 2007.

The Minister for Health and Children, in exercise of the powers conferred on her by section 32 of the Irish Medicines Board Act 1995 (No. 29 of 1995), as amended by section 16 of the Irish Medicines Board (Miscellaneous Provisions) Act 2006 (No. 3 of 2006) and by the European Communities (Amendment of the Irish Medicines Board Act 1995) Regulations 2007 ( S.I. No. 542 of 2007 ) and as adapted by the Health (Alteration of Name of Department and Title of Minister) Order 1997 ( S.I. No. 308 of 1997 ), and including for the purpose of giving effect to Directive 2001/83/EC (as amended by Directive 2004/27/EC), hereby make the following regulations—

PART 1 GENERAL PROVISIONS

Citation.

1. These Regulations may be cited as the Medicinal Products (Control of Placing on the Market) Regulations 2007.

Commencement.

2. These Regulations shall come into force on 23rd July 2007.

Interpretation.

3. (1) In these Regulations—

‘Act’ means the Irish Medicines Board Act 1995 as amended by the Irish Medicines Board (Miscellaneous Provisions) Act 2006 and by the European Communities (Amendment of the Irish Medicines Board Act 1995) Regulations 2007;

‘Agency’ means the European Medicines Agency established by Regulation (EC) No. 726/2004/EC 1 ;

‘Board’ means the Irish Medicines Board established by section 3 of the Irish Medicines Board Act 1995 ;

‘certificate of registration’ means a certificate of registration granted by the Board in accordance with these Regulations in respect of a homeopathic medicinal product that satisfies the conditions specified in Article 14(1) of the 2001 Directive;

‘certificate of traditional-use registration’ means a certificate of traditional-use registration granted by the Board in accordance with these Regulations in respect of a traditional herbal medicinal product;

‘Commission’ means the Commission of the European Community;

‘Community’ means the European Community;

‘Community marketing authorisation’ means a marketing authorisation granted by the European Commission under Regulation (EEC) No. 2309/93 2 or Regulation (EC) No 726/2004;

‘Community Regulation on medicinal products for paediatric use’ means Regulation (EC) No. 1901/2006 of the European Parliament and of the Council 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 3 , as amended by Regulation (EC) No. 1902/2006 of the European Parliament and of the Council amending Regulation 1901/2006 on medicinal products for paediatric use 4 ;

‘2001 Directive’ means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use 5 as amended by—

(a) Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components 6 ,

(b) Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use 7 ,

(c) Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use 8 , and

(d) Directive 2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use 9 ;

‘EEA Agreement’ means the Agreement on the European Economic Area signed in Oporto on 2 May 1992 as adjusted by the Protocol to that Agreement done at Brussels on 17 March 1993 10 ;

‘EEA State’ means a State, which is a contracting party to the EEA Agreement;

‘European Economic Area’ means the European Economic Area created by the EEA Agreement;

‘general sale’, in respect of a medicinal product, means that the product may be sold in a pharmacy and in any other outlet which is not a pharmacy and that it is a product to which the exemption referred to in subparagraph (ii) of section 32(2)(m) of the Act refers;

‘herbal medicinal product’ means any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations;

‘homeopathic medicinal product’ means any medicinal product, which may contain a number of principles, prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in an EEA State. The term also includes anthroposophic medicinal products described in an official pharmacopoeia and prepared by a homeopathic method;

‘herbal preparations’ mean preparations obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. These include comminuted or powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates;

‘herbal substances’ mean all mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually dried, form, but sometimes fresh. Certain exudates that have not been subjected to a specific treatment are also considered to be herbal substances. Herbal substances are precisely defined by the plant part used and the botanical name according to the binomial system (genus, species, variety and author);

‘marketing authorisation’ means an authorisation granted by the Board in accordance with these Regulations in respect of a medicinal product and includes an authorisation granted in accordance with Article 126a of the 2001 Directive, a product authorisation, a parallel import licence and an authorisation granted in accordance with Regulation 11;

‘medicinal product’ has the meaning assigned to it in section 1(1) of the Irish Medicines Board Act 1995 , as amended by section 10(c) of the Irish Medicines Board (Miscellaneous Provisions) Act 2006 ;

‘medicinal product authorised for a paediatric indication’ means a medicinal product which is authorised for use in part or all of the paediatric population and in respect of which the details of the authorised indication are specified in the summary of the product characteristics;

‘Minister’ means the Minister for Health and Children;

‘paediatric use marketing authorisation’ means a...