Medicinal Products (Control of Manufacture) (Amendment) Regulations 2013

• Jurisdiction: Ireland

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 Manufacture) (Amendment) Regulations 2013.

(2) These Regulations shall be construed as one with the Medicinal Products (Control of Manufacture) Regulations 2007 to 2010 and the Medicinal Products (Control of Manufacture) (Amendment) Regulations 2012 (S.I. 273 of 2012), and may be cited together with those Regulations as the Medicinal Products (Control of Manufacture) Regulations 2007 to 2013.

2. In these Regulations “Principal Regulations” means the Medicinal Products (Control of Manufacture) Regulations 2007 ( S.I. No. 539 of 2007 ).

3. Regulation 3(1) (as amended by the Medicinal Products (Control of Manufacture) (Amendment) Regulations 2012 ( S.I. No. 273 of 2012 )) of the Principal Regulations is amended—

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

“‘active substance’ means any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis;

‘active substances register’ means the register of importers, manufacturers and distributors of active substances maintained by the Board in pursuance of Regulation 14D;”,

(b) by inserting after the definition of “Community” 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 substituting for the definition of “EudraGMP Database” 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 “European Economic Area” the following definition:

“‘excipient’ means any constituent of a medicinal product other than the active substance and the packaging material;”,

(f) by inserting after the definition of “export” 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;”, and

(g) by inserting after the definition of “registered medical practitioner” the following definitions:

“‘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 ;

‘relevant date’ means—

(a) in the case of a medicinal product placed on the market in the State, the date 3 years after the date of publication of the delegated acts adopted by the Commission pursuant to Article 54a(2) of the 2001 Directive, or

(b) in the case of a medicinal product placed on the market of an EEA State which, on 21 July 2011, had in place a system of safety features, the date 6 years after the date of publication of the delegated acts adopted by the Commission pursuant to Article 54a(2) of the 2001 Directive;

‘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 8 of the Principal Regulations is amended by inserting after paragraph (5) the following paragraph:

“(6) The Board shall enter information in the EudraGMDP database in relation to all manufacturer’s authorisations granted.”

5. Regulation 13(3) of the Principal Regulations is amended by substituting for subparagraphs (a) and (b) the following:

“(a) in the case of medicinal products, other than investigational medicinal products and products to which sub-paragraph (b) refers, to ensure that every batch of a medicinal product to which the authorisation relates has been manufactured and checked in compliance with—

(i) the laws in force in the State in respect of such product,

(ii) the provisions of the manufacturer’s authorisation, and

(iii) the provisions of the marketing authorisation, certificate of registration, certificate of traditional-use registration or other standard which relates to the said product,

and, from the relevant date, that safety features, where required, have been affixed on the packaging of any such products;

(b) in the case of medicinal products that have been imported by the authorisation holder, other than investigational medicinal products, to ensure that every batch of such products has undergone—

(i) a full qualitative analysis,

(ii) a quantitative analysis of at least all of the active ingredients, and

(iii) all other tests or checks necessary to ensure that the quality of the medicinal products is in accordance with the requirements of the relevant marketing authorisation, certificate of registration or certificate of traditional-use registration,

and, from the relevant date, that safety features, where required, have been affixed on the packaging of any such products;”.

6. Regulation 14A (inserted by the Medicinal Products (Control of Manufacture) (Amendment) Regulations 2012 ( S.I. No. 273 of 2012 )) of the Principal Regulations is amended—

(a) in paragraph (1), by inserting “repeated” after “ by means of”,

(b) in paragraph (5), by substituting “EudraGMDP database” for “EudraGMP database”,

(c) by substituting for paragraphs (6) and (7) the following paragraphs:

“(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,

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

(c) the principles and guidelines of good manufacturing practice for active substances,

(d) the guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients,

(e) the principles and guidelines of good distribution practice, or

(f) the principles and guidelines of good distribution practices for active substances,

the Board shall enter the information in the EudraGMDP database.

(7) If the outcome of an inspection referred to in paragraph (1)...