Medicinal Products (Control of Manufacture) Regulations, 2007

• Jurisdiction: Ireland
• Citation: IR SI 539/2007
• Year: 2007

ARRANGEMENT OF REGULATIONS

1. Citation

2. Commencement

3. Interpretation

4. Requirement for authorisation to manufacture medicinal products (including investigational medicinal products)

5. Exemptions

6. Application for a manufacturer’s authorisation

7. Consideration of an application for a manufacturer’s authorisation

8. Grant or refusal of manufacturer’s authorisation

9. Application and effect of manufacturer’s authorisation

10. Obligations of manufacturers of medicinal products

11. Variation of manufacturer’s authorisation

12. Suspension and revocation of manufacturer’s authorisation

13. Qualified person

14. Particular enforcement obligations

15. Transitional provisions

16. Revocations and amendments

SCHEDULES

1.

Particulars that must accompany an application for a manufacturer’s authorisation

2.

Requirements to be met by an authorisation holder manufacturing medicinal products

3.

Requirements to be met by an authorisation holder importing medicinal products from a third country

4.

Procedural provisions relating to proposals to grant subject to the 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 conditional on the carrying out of certain obligations, and proposals to suspend, vary or revoke a manufacturer’s authorisation

5.

Requirements applicable to qualified persons.

S.I. No. 539 of 2007

MEDICINAL PRODUCTS (CONTROL OF MANUFACTURE) 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 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 Title IV of Directive 2001/83/EC (as amended by Directive 2004/27/EC), Article 13 of Directive 2001/20/EC 1 and Chapter 3 of Commission Directive 2005/28/EC 2 , hereby make the following regulations—

Citation.

1. These Regulations may be cited as the Medicinal Products (Control of Manufacture) 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 ( S.I. No. 542 of 2007 );

‘authorisation holder’ means the holder of a manufacturer’s authorisation;

‘authorised medicinal product’ means a medicinal product which is the subject of a marketing authorisation, certificate of registration or certificate of traditional-use registration;

‘authorised officer’ has the meaning assigned to it in section 32A of the Act;

‘batch’ means a quantity which is homogeneous in character and quality, produced during a given cycle of manufacture;

‘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 which is for the time being in force and which has been granted by the Board under the Medicinal Product (Control of Placing on the Market) Regulations 2007 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 which is for the time being in force and which has been granted by the Board under the Medicinal Products (Control of Placing on the Market) Regulations 2007 in respect of a traditional herbal medicinal product;

‘Commission’ means the Commission of the European Community;

‘Community’ means the European Community;

‘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 3 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 4 ,

(b) Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use 5 ,

(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 6 , 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 7 ;

‘dispensing pharmacy’ means a shop being lawfully kept open for the dispensing or compounding of medical prescriptions under the Pharmacy Acts 1875 to 1977 and includes the pharmaceutical department of a hospital;

‘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 8 ;

‘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;

‘exempt medicinal product’ means a medicinal product to which paragraph 2 of Schedule 1 to the Medicinal Products (Control of Placing on the Market) Regulations 2007, or any equivalent legislation in any EEA State other than the State, applies;

‘export’ means exportation to a third country;

‘GMP Directive’ means Commission Directive 2003/94/EC 9 of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use;

‘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;

‘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);

‘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;

‘import’ means importation from a third country;

‘investigational medicinal product’ means a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including a medicinal product that is already the subject of a marketing authorisation, but—

(a) is used, formulated or packaged in a way different from the form that is the subject of the authorisation,

(b) is used for an indication that is not included in the summary of product characteristics under the authorisation for the product, or

(c) is used to gain further information about the form of the product that is the subject of the authorisation;

‘manufacture’ includes total and partial manufacture, and the various processes of dividing up, packaging and presentation;

‘manufacturer’s authorisation’ means an authorisation which is for the time being in force and which has been granted by the Board in pursuance of Regulation 8;

‘marketing authorisation’ means an authorisation which is for the time being in force and which has been granted by the Board under the Medicinal Products (Control of Placing on the Market) Regulations 2007 or by the Commission under Regulation (EEC) No. 2309/93 10 or Regulation (EC) No 726/2004 11 and includes a marketing authorisation issued by the competent authority of an EEA State, other than the State, in accordance with the 2001 Directive;

‘medicinal product’ includes an investigational medicinal product;

‘Minister’ means the Minister for Health and Children;

‘pharmacist’ means a registered pharmaceutical chemist or a registered dispensing chemist and druggist, under the Pharmacy Acts 1875 to 1977;

‘qualified person’ means—

(a) a person with the qualifications and experience specified in Schedule 5, and named in the manufacturer’s authorisation as being responsible at the manufacturer’s premises for the functions set out in Regulation 13(3), or

(b) insofar as the activities of the qualified person are limited to traditional herbal medicinal products, a person who—

(i) on the date of coming into force of these Regulations, without satisfying the requirements referred to in paragraph (a), has been engaged in activities equivalent to those that are to be...