Medicinal Products (Control of Wholesale Distribution) Regulations, 2007

• Jurisdiction: Ireland

S.I. No. 538 of 2007

MEDICINAL PRODUCTS (CONTROL OF WHOLESALE DISTRIBUTION) REGULATIONS 2007

ARRANGEMENT OF REGULATIONS

1. Citation

2. Commencement

3. Revocations

4. Interpretation

5. Requirement for authorisation to sell medicinal products by wholesale

6. Exemptions

7. Application for a wholesaler’s authorisation

8. Consideration of an application for a wholesaler’s authorisation

9. Grant or refusal of wholesaler’s authorisation

10. Application and effect of wholesaler’s authorisation

11. Obligations of wholesalers of medicinal products

12. Variation of wholesaler’s authorisation

13. Suspension and revocation of wholesaler’s authorisation

14. Particular enforcement obligations

15. Transitional provisions

SCHEDULES

1. Particulars that must accompany an application for a wholesaler’s authorisation

2. Requirements to be met by the authorisation holder

3. Procedural provisions relating to proposals to grant otherwise than in accordance with the holder’s application, proposals to refuse to grant or vary, and proposals to suspend, vary or revoke a wholesaler’s authorisation.

S.I. No. 538 of 2007

MEDICINAL PRODUCTS (CONTROL OF WHOLESALE DISTRIBUTION) 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 VII of Directive 2001/83/EC (as amended by Directive 2004/27/EC), hereby make the following regulations:—

Citation

1. These Regulations may be cited as the Medicinal Products (Control of Wholesale Distribution) Regulations 2007.

Commencement

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

Revocation

3. The Medical Preparations (Wholesale Licences) Regulations 1993 ( S.I. No. 39 of 1993 ) (as amended) are hereby revoked.

Interpretation

4. (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 wholesaler’s authorisation;

‘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 ( S.I. No. 540 of 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;

‘2001 Directive’ means Directive 2001/83/EC 1 of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use, as amended by Directives 2002/98/EC 2 , 2004/24/EC 3 and 2004/27/EC 4 of the European Parliament and of the Council;

‘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 5 ;

‘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 sourced medicinal product’ means an exempt medicinal product that is either imported from another EEA State or is sourced in the State from the holder of a manufacturer’s authorisation;

‘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;

‘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;

‘manufacturer’s authorisation’ means an authorisation granted and in force in pursuance of Regulation 8 of the Medicinal Products (Control of Manufacture) Regulations 2007 ( S.I. No. 539 of 2007 );

‘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 6 or Regulation (EC) No 726/2004 7 and includes a marketing authorisation issued by the competent authority of an EEA State, other than the State, in accordance with the 2001 Directive;

‘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;

‘pre-hospital emergency care provider’ has the same meaning as in the Pre-Hospital Emergency Care Council (Establishment) Order 2000, as amended by the Pre-Hospital Emergency Care Council (Establishment) Order 2000 (Amendment) Order 2004 ( S.I. No. 575 of 2004 );’

‘registered dentist’ means a person registered in the register established under the Dentists Act 1985 (No. 9 of 1985);

‘registered dispensing optician’ means a person registered in the register of dispensing opticians established under the Opticians Acts 1956 and 2003;

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

‘registered optometrist’ means a person registered in the Register of Optometrists established under the Opticians Acts 1956 to 2003;

‘registered veterinary practitioner’ means a person registered in the register established under the Veterinary Practice Act 2005 (No. 22 of 2005);

‘responsible person’ means the person referred to in paragraph 6 of Schedule 2;

‘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. Such term shall also include all activities consisting of the procuring, holding or exporting of medicinal products other than activities involving the sale or supply of such products to the public;

‘traditional herbal medicinal product’ means a herbal medicinal product that satisfies the conditions specified in Article 16a of the 2001 Directive;

‘wholesaler’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 9.

(2) In these Regulations, unless the context otherwise requires—

(a) any reference to a Regulation or Schedule shall be construed as a reference to a Regulation contained in these Regulations or, as the case may be, to a Schedule thereto, and

(b) any reference in a Regulation, or a Schedule, to a paragraph shall be construed as a reference to a paragraph in that Regulation or Schedule and in a paragraph, any reference to a subparagraph shall be construed as a reference to a subparagraph in that paragraph.

(3) A word or expression which is used in these Regulations and which is also used in the 2001 Directive has, unless the context otherwise requires, the same meaning in these Regulations as it has in that Directive.

Requirement for authorisation to sell medicinal products by wholesale

5. Subject to the provisions of these Regulations, a person shall not sell by wholesale, or offer or keep for sale by wholesale, any medicinal product unless he or she is the holder of a wholesaler’s authorisation.

Exemptions

6. The provisions...