IE
S.I. No. 538/2007 - Medicinal Products (Control of Wholesale Distribution) Regulations 2007
Table of Provisions (18)
Statutory Text (18 Articles)
1. In this Schedule—
‘authorisation’ means a wholesaler’s authorisation; and
‘time allowed’ means the period of 28 days or such extended period as the Board may in any particular case allow.
2. Subject to paragraph 6, if the Board proposes—
(
a
) not to grant an authorisation;
(
b
) to grant an authorisation other than in accordance with the application,
(
c
) to revoke, vary or suspend an authorisation; or
(
d
) not to vary an authorisation on the holder’s application to vary,
the Board shall notify the applicant or authorisation holder accordingly.
3. Any notification given under paragraph 2 shall include—
(
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 authorisation holder has the right to make representations to the Board in response to the notification.
4. A person to whom notification has been given under paragraph 2 may, within the time allowed after the notification was given, give notice to the Board of his or her wish to do so, and make representations to the Board with respect to the decision or proposal referred to in the notification.
5. The Board shall, after consideration of the representations, decide whether to grant the authorisation, revoke, vary or suspend the authorisation or confirm or alter its decision, as the case may be.
6. (1) Paragraph 2 shall not apply to the suspension of an authorisation where it appears to the Board that, in the interests of safety, it is necessary to suspend the authorisation with immediate effect for a period not exceeding 3 months.
(2) If, after the aforementioned suspension has taken effect, it appears to the Board that the authorisation should be further suspended or revoked, the Board shall proceed in accordance with the provisions of paragraphs 2 to 5.
GIVEN under my 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 TITLE VII of Directive 2001/83/EC (as amended by Directive 2004/27/EC) relating to the wholesale distribution of medicinal products for human use. The Regulations also consolidate and update the existing Regulations, which they replace.
1 OJ L. 311, 28.11.2001, p.67.
2 OJ L. 33, 08.02.2002, p.30.
3 OJ L. 136, 30.04.2004, p.85.
4 OJ L. 136, 30.4.2004, p.34.
5 OJ No. L 1, 03.01.1994, p.572.
6 OJ No. L.214, 24.08.1993, p.1
7 OJ No. L 136, 30.04.2004, p. 1.
8 OJ No. C 63, 01.03.1994, p.4.
7. The authorisation holder shall notify the Board of any proposed structural alteration to, or discontinuation of use of, premises to which the authorisation relates or premises that have been approved from time to time by the Board.
8. (1) The authorisation holder shall keep available for inspection by officers of the Board, for a period of not less than five years, records giving for each transaction in respect of medicinal products received or dispatched at least the following information
— the date of receipt or supply,
— the name of the medicinal product,
— the quantity received or supplied, and
— the name and address of the supplier or consignee, as appropriate.
(2) The records referred to in subparagraph (1) may be provided via image medium or other data medium, provided that the data, when made readable, match the original documentation in appearance and content, are available at all times, can be made readable without delay and can be analysed by automated means.
9. The authorisation holder shall have an emergency plan which will ensure the effective implementation of any recall from the market of any such product, or batch thereof, that may be ordered by the Board or carried out in cooperation with the manufacturer or holder of the marketing authorisation for the medicinal product concerned.
10. The authorisation holder, in making a sale by wholesale to persons referred to in paragraph 4(
d
) and (
e
), shall enclose with the medicinal product a document that makes it possible for such persons to ascertain
— the date on which the sale took place,
— the name and pharmaceutical form of the product supplied,
— the quantity of the product supplied, and
— the name and address of the supplier and consignor.
11. The authorisation holder shall, in respect of a medicinal product that has actually been placed on the market in the State and within the limits of his or her responsibility, ensure appropriate and continued supplies of that product to the persons referred to in paragraph 4(
d
) and (
e
), so that the needs of patients in the State in respect of such medicinal product are covered.
12. The authorisation holder, if he or she proposes to import from another EEA State a medicinal product in respect of which he or she is not the holder of the relevant marketing authorisation, or is not acting on behalf of such a person, shall notify the holder of the marketing authorisation concerned and the Board, of his or her intention to import the product.
13. The authorisation holder shall comply with the principles and guidelines of good distribution practice for medicinal products
8
published by the Commission under Article 84 of the 2001 Directive.
8 OJ No. C 63, 01.03.1994, p.4.
14. The authorisation holder shall, on being informed by the Board or by the holder of the marketing authorisation, that any batch of any medicinal product to which the wholesaler’s authorisation relates, has been found not to conform as regards the provisions of the relevant marketing authorisation, or as regards the strength, quality or purity with the appropriate specification for that product, if so directed, immediately withhold such batch from sale or exportation, and if so directed by the Board, insofar as may be reasonably practicable, immediately withdraw from sale any supplies of that batch held by him or her and immediately recall all supplies already sold or distributed from that batch.
15. The authorisation holder shall, on being informed by the Board that a medicinal product to which the wholesaler’s authorisation relates, has been found to give rise to concerns in regard to its safety or efficacy, if so directed by the Board, immediately withhold such product from sale, supply or exportation and insofar as may be reasonably practicable, immediately recall all supplies already sold or distributed by him or her.
16. The authorisation holder shall permit at all reasonable times such inspections, by officers of the Board, as may be required to satisfy the Board that the conditions of the authorisation are being complied with.
17. (1) Where and insofar as the wholesaler’s authorisation relates to an exempt sourced medicinal products, the authorisation holder shall only source such products—
(
a
) in response to an order, or in anticipation of an order, which satisfies the requirements of paragraph 2 of Schedule 1 to the Medicinal Products (Control of Placing on the Market) Regulations 2007; and
(
b
) where the conditions set out in subparagraphs (2) to (9) are complied with.
(2) The authorisation holder shall, in the case of each consignment of an exempt sourced medicinal product received by him or her, make, and keep available for inspection by officers of the Board, for a period of not less than five years, written records showing the following particulars—
(
a
) the name of the medicinal product, being the brand name or the common name, or the scientific name, and any name, if different, under which the particular medicinal product is to be sold or supplied in the State;
(
b
) the dosage form;
(
c
) the trading style or name of the manufacturer of the medicinal product;
(
d
) in respect of each active constituent of the medicinal product, any international non-proprietary name or the monograph name or, where that constituent does not have an international non-proprietary name, the accepted scientific name or any other name descriptive of the true nature of that constituent;
(
e
) the quantity of medicinal product which has been received;
(
f
) the batch number of the medicinal product which has been received; and
(
g
) the name and address of the manufacturer of that medicinal product in the form in which it was received and, if the person who supplied the medicinal product is not the manufacturer, the name and address of such supplier.
(3) Where the authorisation holder sells or supplies an exempt sourced medicinal product, he or she shall, in addition to those records mentioned in paragraph 8(1) and subparagraph (2), make and maintain written records relating to—
(
a
) the batch number of the batch of the product from which each sale or supply was made;
(
b
) details of any suspected adverse reaction to the product so sold or supplied of which he or she becomes aware; and
(
c
) details of any quality defect relating to the product so sold or supplied of which he or she becomes aware.
(4) The authorisation holder shall not issue any advertisement, catalogue, price list or circular relating to the exempt sourced medicinal product or make any representations in respect of that product.
(5) The authorisation holder shall inform the Board forthwith of any matter, including suspected adverse reactions and quality defects, coming to his or her attention, in respect of an exempt sourced medicinal product that has been sourced by him or her.
(6) The authorisation holder shall cease supplying an exempt sourced medicinal product if he or she has received a notice in writing from the Board directing that, as from a date specified in that notice, a particular product or class of products shall no longer be sourced or supplied.
(7) The authorisation holder shall, on being informed by the Board, or by the manufacturer or person who supplied the medicinal product to the holder of the authorisation, that the medicinal product can not be regarded either as a product which can safely be administered to human beings or as a product which is of satisfactory quality or efficacy for such administration, immediately withdraw any supplies of that product held by him or her and immediately recall all supplies already sold or distributed.
(8) With effect from the 1 January 2008, the authorisation holder shall, not later than seven days of his or her receipt of a consignment of an exempt sourced medicinal product, notify the Board of each such receipt. Each such notification shall include the particulars set out in subparagraph (2).
(9) With effect from the 1 January 2009, the notifications referred to in subparagraph (8) shall, except in exceptional circumstances, be communicated electronically to the Board and within a timeframe of two working days from the date of the receipt of each such consignment.
(10) In this paragraph—
‘common name’ means the international non-proprietary name, or, if one does not exist, the usual common name;
‘international non-proprietary name’ means the international non-proprietary name recommended by the World Health Organisation; and
‘monograph name’ means the name or approved synonym which appears at the head of a monograph in the current edition of the European Pharmacopoeia, the British Pharmacopoeia, or a foreign or international compendium of standards and ‘current’ in this definition means current at the time the notice is sent to the Board.
(Regulations 9(4), 12(6) and 13(3))
SCHEDULE 3 PROCEDURAL PROVISIONS RELATING TO PROPOSALS TO GRANT OTHERWISE THAN IN ACCORDANCE WITH THE 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
ARRANGEMENT OF REGULATIONS