S.I. No. 540/2007 - Medicinal Products (Control of Placing on the Market) Regulations 2007

• (4)
• (a) The provisions of these Regulations shall not apply until 30 April 2011 to traditional herbal medicinal products that were on the market in the State on the coming into force of these Regulations.

• (b) Notwithstanding clause (a) of this subparagraph and with a view to ensuring that certificates of traditional-use registration are held by the 30 April 2011, the Board may establish and publish dates by which applications in accordance with these Regulations, for such certificates shall be made in respect of such products or classes of such products as the Board may specify, and the Board shall consider each such application as provided for in these Regulations.

• (5)
• (a) The provisions of these Regulations shall not apply until 30 April 2011 to homeopathic medicinal products to which Regulation 11 applies and which were on the market in the State on the coming into force of these Regulations.

• (b) Notwithstanding clause (a) of this subparagraph and with a view to ensuring that marketing authorisations are held by the 30 April 2011, the Board may establish and publish dates by which applications in accordance with these Regulations, for such authorisations shall be made in respect of such products or classes of such products as the Board may specify, and the Board shall consider each such application as provided for in these Regulations.

Revocation.

• (2) With effect from the 30 October 2010, the Medical Preparations (Labelling and Package Leaflets) Regulations 1993 ( S.I. No. 71 of 1993 ) (as amended) shall be revoked

PART 6 AMENDMENT OF EUROPEAN COMMUNITIES (CLINICAL TRIALS ON MEDICINAL PRODUCTS FOR HUMAN USE) REGULATIONS 2004

• (a) the insertion of the following after the definition of “Commission Directive 2003/94/EC”—

“ ‘Community marketing authorisation’ has the meaning assigned to it by Regulation 3(1) of the Medicinal Products (Control of Placing on the Market) Regulations 2007 ( S.I. No. 540 of 2007 );”; and

• (b) the substitution of the following for the definition of “marketing authorisation”—

“ ‘marketing authorisation’ has the meaning assigned to it by Regulation 3(1) of the Medicinal Products (Control of Placing on the Market) Regulations 2007 and includes a Community marketing authorisation;”.

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

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 5

• (a) any medicinal product intended for research and development trials, but without prejudice to the provisions of the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 ( S.I. No. 190 of 2004 ) (as amended);

• (b) to the sale or supply of a medicinal product in accordance with any exception or exemption set out in the 2001 Directive;

• (c) the importation of a medicinal product, from a country that is not an EEA State, by a person for his own personal use, not being an importation resulting directly from a mail order advertisement directed at members of the public.

• (a) the medicinal product is supplied to a practitioner or for use in a pharmacy under the supervision of a pharmacist, in accordance with paragraph 2;

• (b) no advertisement or representation relating to the medicinal product is issued with a view to it being seen by the general public in the State and that no advertisement relating to the product, by means of any catalogue, price list or circular letter is issued by, at the request or with the consent of, the person selling the product by retail or by way of wholesale dealing or the person who manufactures it, and that the sale or supply is in response to a bona fide unsolicited order;

• (c) the manufacture of the medicinal product is carried out under the supervision of such staff and such precautions are taken as are adequate to ensure that the product is of the character required by and meets the specifications of the practitioner who requires it;

• (d) written records as to the manufacture in accordance with subparagraph (c) are made and maintained and are available to the Board on request;

• (e) if the medicinal product is manufactured in the State, or imported into the State from a third country, the product—

• (i) is manufactured or imported by the holder of a manufacturer’s authorisation which relates specifically to the manufacture or import of the medicinal product to which paragraph 2 applies; or

• (ii) has been manufactured or imported as an investigational medicinal product by the holder of a manufacturing authorisation granted by the Board in respect of such products under Regulation 37 of the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 or Regulation 8 of the Medicinal Products (Control of Manufacture) Regulations 2007; and

• (f) the medicinal product is distributed by way of wholesale dealing by the holder of a wholesaler’s authorisation or by the person who has manufactured or imported the product, being the holder of a manufacturer’s authorisation which relates specifically to the manufacture or importation of the medicinal product concerned.

• (a) by a practitioner which relates to a medicinal product specially prepared by him, or to his order, for administration to one or more of his patients, and consists of procuring the manufacture of a stock of the product with a view to administering it to such patients; or

• (b) in a pharmacy and is done there by or under the supervision of a pharmacist, and consists of procuring the manufacture of a stock of medicinal products with a view to dispensing them in accordance with paragraph 2.

• (2) The exemption conferred by subparagraph (1) shall not apply to procuring the manufacture of medicinal products unless those products are to be manufactured by the holder of an authorisation referred to in Article 40 of the 2001 Directive which relates specifically to the manufacture of the medicinal products to which paragraph 2 applies.

• (3) The exemption conferred by subparagraph (1) shall not apply to anything done by a practitioner in relation to a stock held by him or her of such medicinal products in excess of 3 litres of fluid and 1 kilogram of solids of all medicinal products to which that subparagraph relates.

• (2) The medicinal products to which this paragraph applies are medicinal products for use by being administered to one or more human beings and which may be lawfully sold or supplied otherwise than in accordance with a prescription given by a practitioner.

• (3) The conditions referred to in subparagraph (1) are that—

• (a) the medicinal product is sold or supplied to a person exclusively for use by him or her in the course of a business carried on by him or her for the purposes of administering it or causing it to be administered to one or more human beings otherwise than by selling it;

• (b) if sold or supplied through the holder of a wholesaler’s authorisation, the medicinal product is sold or supplied to such a person, and for such use by him, as is described in subparagraph (3)(a) above;

• (c) where the manufacture of the medicinal product is procured, it is procured by such a person, and for such use by him, as is described in subparagraph (3)(a) above;

• (d) the medicinal product is prepared by or under the supervision of a pharmacist;

• (e) if the medicinal product is manufactured in the State, or is imported into the State from a third country, the product is manufactured or imported by the holder of a manufacturer’s authorisation which relates specifically to the manufacture or import of the medicinal product to which paragraph 2 applies; and

• (f) no advertisement or representation relating to the medicinal product is issued with a view to it being seen by the general public in the State and that no advertisement relating to the product, by means of any catalogue, price list or circular letter is issued by, at the request or with the consent of, the person selling that product by retail or by way of wholesale dealing or the person who manufactures it, and that the sale or supply is in response to a bona fide unsolicited order.

• (2) In this paragraph—

‘generator’ means any system incorporating a fixed parent radionuclide from which is produced a daughter radionuclide which is to be removed by elution or by any other method and is to be used in a radiopharmaceutical;

‘kit’ means any product to be reconstituted or combined with radionuclides in a final radiopharmaceutical, usually prior to administration;

‘precursor’ means a radionuclide produced for the radio-labelling of another substance prior to its administration, other than a radionuclide which is incorporated in or produced from a generator or is included in a radiopharmaceutical;

‘radiopharmaceutical’ means any medicinal product which, when ready for use, contains one or more radionuclides intended for a medicinal purpose.

• (3) Nothing in this paragraph shall permit the handling of a medicinal product which is a radiopharmaceutical, in contravention of the provisions of the Radiological Protection Act, 1991 (Ionising Radiation) Order 2000 ( S.I. No. 125 of 2000 ) or the administration of any such product in contravention of the provisions of the European Communities (Medical Ionising Radiation Protection) Regulations 2002 ( S.I. No. 478 of 2002 ).

• (a) the source from which that person obtained the product;

• (b) the person to whom and the date on which the sale or supply was made;

• (c) the quantity of each sale or supply;

• (d) the batch number of the batch of that product from which the sale or supply was made; and

• (e) details of any suspected adverse reaction to the product so sold or supplied of which he or she is aware.

• (a) notify the Board of any suspected adverse reaction such as is mentioned in subparagraph (e) thereof which is a serious adverse reaction; and

• (b) make available for inspection at all reasonable times by the Board the records referred to in that paragraph.

Regulations 10(9) and 14(9).

SCHEDULE 2 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 OR CERTIFICATE CONDITIONAL ON THE CARRYING OUT OF CERTAIN OBLIGATIONS, AND PROPOSALS TO SUSPEND, VARY OR REVOKE AN AUTHORISATION OR CERTIFICATE

‘authorisation’ means a marketing authorisation;

‘certificate’ means a certificate of registration or, as the case may be, a certificate of traditional-use registration; and

‘time allowed’ means the period of 28 days or such extended period as the Board may in any particular case allow.

• (a) not to grant an authorisation or certificate,

• (b) to grant an authorisation or certificate subject to the carrying out of certain obligations,

• (c) to grant an authorisation or certificate other than in accordance with the application,

• (d) to revoke, vary or suspend an authorisation or certificate,

• (e) not to vary an authorisation or certificate on the holder’s application to vary, or

• (f) to make an authorisation or certificate conditional on the carrying out of certain obligations,

the Board shall notify the applicant or the holder of the authorisation or certificate accordingly.

• (a) a statement of the proposals of the Board;

• (b) a statement setting out in detail the reasons on which the said proposals are based, and

• (c) a statement that the applicant or the holder of the authorisation or certificate has the right to make representations to the Board in response to the notification.

• (2) If, after the aforementioned suspension has taken effect, it appears to the Board that the authorisation or certificate should be further suspended or revoked, the Board shall proceed in accordance with the provisions of paragraphs 2 to 5.

GIVEN under the Official Seal,

20 July 2007

MARY HARNEY.

Minister for Health and Children.

EXPLANATORY NOTE.

(This note is not part of the Instrument and does not purport to be a legal interpretation).

The main purpose of these Regulations is to implement Directive 2001/83/EC (as amended by Directive 2004/27/EC) insofar as that Directive relates to the placing on the market and marketing of medicinal products for human use.

Footnotes