Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2013

• Jurisdiction: Ireland
• Citation: IR SI 164/2013
• Year: 2013

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 28th May, 2013.

I, JAMES REILLY, Minister for Health, in exercise of the powers conferred on me by section 32 (as amended by section 16 of the Irish Medicines Board (Miscellaneous Provisions) Act 2006 (No. 3 of 2006)) of the Irish Medicines Board Act 1995 (No. 29 of 1995) and for the purpose of giving effect to Directive 2011/62/EU of the European Parliament and of the Council of 8 June 20111 , and for the purpose of giving further effect to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 20012 , hereby make the following regulations:

1. (1) These Regulations may be cited as the Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2013.

(2) These Regulations shall be construed as one with the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 to 2010 and the Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2012 (S.I. 274 of 2012), and may be cited together with those Regulations as the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 to 2013.

2. In these Regulations “Principal Regulations” means the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 ( S.I. No. 538 of 2007 ).

3. Regulation 4(1) (as amended by the Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2012 ( S.I. No. 274 of 2012 )) of the Principal Regulations is amended—

(a) by inserting after the definition of “authorisation holder” the following definitions:

“‘brokering of medicinal products’ means all activities in relation to the sale or purchase of medicinal products, except for wholesale distribution and sale by wholesale, that do not include physical handling and that consist of negotiating independently and on behalf of another legal or natural person;

‘brokers register’ means the register maintained by the Board in pursuance of Regulation 14D;”,

(b) by inserting after the definition of “Commission” the following definitions:

“‘Community marketing authorisation’ means a marketing authorisation granted by the Commission under Regulation (EEC) No. 2309/933 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 of 12 December 20064 , as amended by Regulation (EC) No. 1902/2006 of the European Parliament and of the Council of 20 December 20065 ;”;

(c) by substituting for the definition of “2001 Directive” the following definition:

“‘2001 Directive’ means Directive 2001/83/EC of the European Parliament and of the Council of 6 November 20012, as amended by Directive 2002/98/EC of the European Parliament and of the Council of 27 January 20036 , Commission Directive 2003/63/EC of 25 June 20037 , Directive 2004/24/EC of the European Parliament and of the Council of 31 March 20048 , Directive 2004/27/EC of the European Parliament and of the Council of 31 March 20049 , the Community Regulation on medicinal products for paediatric use, the advanced therapy regulation, Directive 2008/29/EC of the European Parliament and of the Council of 11 March 200810 , Directive 2009/53/EC of the European Parliament and of the Council of 18 June 200911 , Commission Directive 2009/120/EC of 14 September 200912 , Directive 2010/84/EU of the European Parliament and of the Council of 15 December 201013 and Directive 2011/62/EU of the European Parliament and of the Council of 8 June 20111;”,

(d) by inserting after the definition of “EEA State” the following definition:

“‘EudraGMDP database’ means the Union database referred to in Article 111(6) of the 2001 Directive;”,

(e) by inserting after the definition of “exempt medicinal product” the following definition:

“‘falsified medicinal product’ means any medicinal product with a false representation of—

(a) its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients,

(b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder, or

(c) its history, including the records and documents relating to the distribution channels used,

but does not include unintentional quality defects and is without prejudice to infringements of intellectual property rights;”,

(f) by inserting after the definition of “registered veterinary practitioner” the following definition:

“‘Regulation (EC) No. 726/2004’ means Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 200414 , as amended by Regulation (EC) No. 1901/2006 of the European Parliament and of the Council of 12 December 200615 , the advanced therapy regulation, Regulation (EC) No. 219/2009 of the European Parliament and of the Council of 11 March 200916 , Regulation (EC) No. 470/2009 of the European Parliament and of the Council of 6 May 200917 and Regulation (EU) No. 1235/2010 of the European Parliament and of the Council of 15 December 201018 ;”, and

(g) by inserting after the definition of “responsible person” the following definition:

“‘safety features’ means safety features affixed on the packaging of a medicinal product pursuant to Regulation 17 (inserted by Regulation 5 of the Medicinal Products (Control of Placing on the Market) (Amendment) Regulations 2013 (S.I. 162 of 2013)) of the Medicinal Products (Control of Placing on the Market) Regulations 2007 ( S.I. No. 540 of 2007 );”.

4. Regulation 9 of the Principal Regulations is amended by inserting after paragraph (5) the following paragraphs:

“(6) A wholesaler’s authorisation granted under this Regulation shall state the premises within the State for which it is valid.

(7) The Board shall enter information in the EudraGMDP database in relation to every wholesaler’s authorisation granted.”.

5. Regulation 14A (inserted by the Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2012 ( S.I. No. 274 of 2012 )) of the Principal Regulations is amended—

(a) in paragraph (1)—

(i) by substituting “Act, and Article 77(5) and Article 111” for “Act and Article 111”, and

(ii) by inserting “repeated” after “by means of”,

(b) in paragraph (2), by substituting “of good distribution practice” for “on good distribution practice”,

(c) by substituting for paragraph (4) the following paragraphs:

“(4) If the outcome of an inspection referred to in paragraph (1) is that the inspected entity complies with the principles and guidelines of good distribution practice, the Board shall, when applicable, within 90 days of the inspection, issue to the inspected entity a certificate of good distribution practice.

(5) The Board shall enter the certificates of good distribution practice in the EudraGMDP database.

(6) If the outcome of an inspection referred to in paragraph (1) is that the inspected entity does not comply with—

(a) the legal requirements governing medicinal products, or

(b) the principles and guidelines of good distribution practice,

the Board shall enter the information in the EudraGMDP database.

(7) In this Regulation “the principles and guidelines of good distribution practice” means the guidelines19 published by the Commission pursuant to Articles 84 and 85(b)(3) of the 2001 Directive.

(8) The Board may carry out inspections at the premises of brokers of medicinal products.”.

6. The Principal Regulations are amended by inserting after Regulation 14A (inserted by the Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2012 ( S.I. No. 274 of 2012 )) the following Regulations:

“Falsified medicinal products

14B.A person shall not distribute, broker or sell by wholesale a medicinal product if he or she knows, or there are sufficient grounds to suspect, that it is a falsified medicinal product.

Obligations...