The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005

Regulation 4

SCHEDULE AMENDMENTS TO OTHER ENACTMENTS

1.  In the Medicines (Pharmacy and General Sale Exemption) Order 1980(1) in article 1 (citation, commencement and interpretation), in paragraph (2)—

(a) in the definition of “Community marketing authorization” after “Regulation (EEC) No. 2309/93” insert “or Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency”,

(a) after the definition of “cosmetic” insert the following definition—

““Directive 2001/83/EC” means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as amended by Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components(2), Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use and Directive 2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use”, and

(b) in the definition of “United Kingdom marketing authorization” after “Schedule 6 to those Regulations” insert “or an authorization granted by the licensing authority in accordance with Article 126a of Directive 2001/83/EC”.

2.  In the Medicines (Applications for Grant of Product Licences – Products for Human Use) Regulations 1993(3), in regulation 1 (citation, commencement and interpretation), in paragraph 2, in the definition of “the 2001 Directive”, after “as amended”, insert “by Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components, Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use and Directive 2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use”.

3.  In the Medical Devices (Consultation Requirements) (Fees) Regulations 1995(4), in regulation 1 (citation, commencement and interpretation), in paragraph (2), in the definition of “ authorised medicinal product”, after “Council Regulation (EEC) No 2309/93”, insert “or Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency”.

4.  In the Genetically Modified Organisms (Risk Assessment) (Records and Exemptions) Regulations 1996(5), in regulation 3 (exemptions from requirement to carry out risk assessments), in paragraph (2)(c), after “Council Regulation (EEC) No 2309/93”, insert “or Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency”.

5.  In the Prescription Only Medicines (Human Use) Order 1997(6), in article 1 (citation, commencement and interpretation), in paragraph (2)—

(a) in the definition of “Community marketing authorization”, after “Council Regulation (EEC) No. 2309/93”, insert “or Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency”, and

(b) in the definition of “United Kingdom marketing authorization” after “Schedule 6 to those Regulations” insert “or an authorization granted by the licensing authority in accordance with Article 126a of Directive 2001/83/EC”;

6.  In the Health Service Medicines (Control of Prices of Branded Medicines) Regulations 2000(7) in regulation 2 (interpretation), in paragraph 1—

(a) after the definition of “branded health service medicine” insert the following definition—

““Directive 2001/83/EC” means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as amended by Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components, Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use and Directive 2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use”;

(b) in the definition of “marketing authorisation”—

(i) for sub-paragraph (a), substitute the following—

“(a) by the competent authority of the United Kingdom in accordance with Directive 2001/83/EC and includes an authorisation granted by the competent authority in accordance with Article 126a of Directive 2001/83; or”, and

(ii) in sub-paragraph (b), after “Evaluation of Medicinal Products” insert “or Regulation (EC) No. 726/2004 of the European Parliament and the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency”.

7.  In the Genetically Modified Organisms (Contained Use) Regulations 2000(8) in regulation 3 (application), in paragraph (3) (a) (ii), after “Council Regulation (EEC) No 2309/93”, insert “or Regulation (EC) No. 726/2004 of the European Parliament and the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency”.

8.  In the Biocidal Products Regulations 2001(9) in regulation 3 (application), in paragraph (1)(b), after “Evaluation of Medicinal Products”, insert “or Regulation (EC) No. 726/2004 of the European Parliament and the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency”.

9.  In the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002(10) in regulation 15 (exempt activities), after “Regulation (EEC) 2309/93”, insert “or Regulation (EC) No. 726/2004 of the European Parliament and the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency”.

10.  In the Medical Devices Regulations 2002(11), in regulation 2 (interpretation), in paragraph (1), in the definition of “Directive 2001/83”, after “human use” insert “as amended by Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components, Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use and Directive 2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use”.

11.  In the Genetically Modified Organisms (Deliberate Release) Regulations 2002(12), in regulation 15 (exempt activities), in paragraph (e), after “Commission Regulation EC No. 649/98”, insert “or Regulation (EC) No. 726/2004 of the European Parliament and the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency”.

12.  In the Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002 (Rheoliadau Organeddau A Addaswyd Yn Enetig (Eu Gollwng Yn Fwriadol) (Cymru) 2000) (13) in regulation 16 (exempt activities) (gweithgareddau esempt),in paragraph (e), in the English text, after “Commission Regulation EC No. 649/98”, insert “or Regulation (EC) No. 726/2004 of the European Parliament and the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency” and in the Welsh text, after “Reoliad y Comisiwn EC Rhif 649/98” insert “neu Reoliad (EC) Rhif 726/2004 Senedd Ewrop a'r Cyngor sy'n gosod gweithdrefnau'r Gymuned ar gyfer awdurdodi a goruchwylio cynhyrchion meddyginiaethol at ddefnydd pobl ac anifeiliaid a sefydlu Asiantaeth Meddyginiaethau Ewrop”.

13.  In the Food Supplements (England) Regulations 2003(14), in regulation 3 (scope of regulations), in paragraph (2), after “human use”, insert “as amended by Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components, Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use and Directive 2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use”.

14.  In the Food Supplements (Scotland) Regulations 2003(15) in regulation 3 (scope of regulations) in paragraph (2), after “human use”, insert “as amended by Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components, Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use and Directive 2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use”.

15.  In English text of the Food Supplements (Wales) Regulations 2003(16)(Rheoliadau Ychwanegion Bwyd (Cymru) 2003)(17), in regulation 3 (scope of regulations) in paragraph (2), after “human use”, insert “as amended by Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components, Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use and Directive 2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use”. In the Welsh text of the Regulations, in regulation 3 (scope of regulations) in paragraph (2), after “i bobl eu defnyddio”, insert “fel y”i diwygiwyd gan Gyfarwyddeb 2002/98/EC Senedd Ewrop a'r Cyngor sy'n gosod safonau ansawdd a diogelwch ar gyfer casglu, profi, prosesu, storio a dosbarthu gwaed a chydrannau gwaed dynol , Cyfarwyddeb y Comisiwn 2003/63/EC sy'qn diwygio Cyfarwyddeb 2001/83/EC ar god y Gymuned ynglŷn â chynhyrchion meddyginiaethol i bobl eu defnyddio, Cyfarwyddeb 2004/24/EC Senedd Ewrop a'r Cyngor sy'n diwygio, o ran cynhyrchion meddyginiaethol llysieuol traddodiadol, Gyfarwyddeb 2001/83/EC ar god y Gymuned ynglŷn â chynhyrchion meddyginiaethol i bobl eu defnyddio a Chyfarwyddeb 2004/27/EC Senedd Ewrop a'r Cyngor sy'n diwygio Cyfarwyddeb 2001/83/EC ar god y Gymuned ynglŷn â chynhyrchion meddyginiaethol i bobl eu defnyddio”.

16.  In the National Health Service (General Medical Services Contracts) (Wales) Regulations 2004(18) in paragraph 43 of Schedule 6 (restrictions on prescribing by supplementary prescribers), in sub-paragraph (6), after “human use”, insert “as amended by Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components, Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use and Directive 2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use”.

17.  In the Medicines for Human Use (Clinical Trials) Regulations 2004(19), in regulation 2 (interpretation), in paragraph (1)—

(a) in the definition of “Directive 2001/83/EC” after “as amended” insert “by Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components, Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use and Directive 2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use”,

(b) in the definition of “marketing authorization”, in paragraph (c), after “Council Regulation (EEC) 2309/93”, insert “or Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency”.

18.  In the General Product Safety Regulations 2005(20) in regulation 33 (duty to notify), in paragraph (10)(b), after “human use”, insert “as amended by Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components, Commission Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use and Directive 2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use”.

19.  In Schedule 13 to the Enterprise Act 2002(21), for paragraph 11 substitute the following—

“11.   Articles 83 to 100 of the Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products for human use as read with—

(a) Directive 2004/24/EC of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, the code, and

(d) Directive 2004/27/EC of the European Parliament and of the Council also amending the code.”.

(1)

S.I. 1980/1924; relevant amending instrument is S.I. 2000/1919.

(2)

OJ No. L33, 8.2.2003, p.30.

(3)

S.I. 1993/2538; relevant amending instruments are S.I. 2002/236 and S.I. 2003/2321.

(4)

S.I. 1995/449.

(5)

S.I. 1996/1106.

(6)

S.I 1997/1830; relevant amending instrument is S.I.2000/1917.

(7)

S.I. 2000/123; relevant amending instruments are S.I. 2002/236 and S.I. 2004/3224.

(8)

S.I 2000/2831.

(9)

S.I. 2001/880.

(10)

S.I. 2002/541.

(11)

S.I. 2002/618.

(12)

S.I. 2002/2443.

(13)

S.I. 2002/3188.

(14)

S.I.2003/1387.

(15)

S.I.2003/278.

(16)

S.I. 2003/1719.

(17)

S.I. 2003/1719.

(18)

S.I. 2004/478.

(19)

S.I. 2004/1031.

(20)

S.I. 2005/1803.

(21)

c.40; relevant amending instrument is S.I. 2003/1374.