Drug Dye Ordinance (AMFarbV)

Unofficial table of contents

AMColorV

Date of completion: 17.10.2005

Full quote:

" Ordinance of the Medicines Act of 17. October 2005 (BGBl. 3031), as defined by Article 8 of the Law of 17 July 2009 (BGBl I). 1990).

Status:

Amended by Art. 8 G v. 17.7.2009 I 1990

For more details, please refer to the menu under Notes
This Regulation shall be used for the implementation of

-

Directive 2001 /82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 327, 30.12.2001, p. EC No L 311 p. 1)

and 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 (OJ L 311, 28.11.2001, p. EC No L 311 p. 67).

Footnote

(+ + + Text evidence from: 27.10.2005 + + +) 
(+ + + Official note from the norm-provider on EC law: 
 Implementation of the 
 ERL 82/2001 (CELEX Nr: 301L0082) 
 EGRL 83/2001 (CELEX Nr: 301L0083) + + +) 

  

Unofficial table of contents

Input formula

Order it

-

the Federal Ministry of Health and Social Protection on the basis of section 6 (1) sentence 1 and section 83 (1) and (2) of the Medicines Act, as amended by the Notice of 11 December 1998 (BGBl. 3586), of which Article 6 (1) was last amended by Article 1 (4) (a) of the Law of 30 July 2004 (BGBl). 2031),

-

the Federal Ministry of Consumer Protection, Food and Agriculture on the basis of section 6 (1) sentence 1 in conjunction with sentence 2 and section 83 (1) and (2) of the Medicines Act as amended by the Notice of 11 December 1998 (BGBl. 3586), of which Article 6 (1) was last amended by Article 1 (4) (a) of the Law of 30 July 2004 (BGBl). 2031), in agreement with the Federal Ministry of Health and Social Protection:

Unofficial table of contents

§ 1

(1) In the manufacture of medicinal products within the meaning of Article 2 (1) of the Medicinal Products Act, which are intended to do so, in a Member State of the European Communities or in another State Party to the Agreement on the European Union In order to be placed on the market, only those listed in Annex I to Directive 94 /36/EC of the European Parliament and of the Council of 30 June 1994 on colouring matters which may be used in foodstuffs may be used for colouring matters (OJ L 327, 31.12.1994, p. EC No 13), substances or preparations of these substances listed in the current version are used; these substances and their preparations must comply with the purity criteria set out in the Annex to Commission Directive 95 /45/EC of 26 June 2002 on the basis of the purity criteria set out in Annex I to the Commission Directive 95 /45/EC of 26 July 1995 laying down specific purity criteria for food colours (OJ L 327, 30.4.1995, p. EC No 1), as amended in each case. If dyes are described in monographs of the European Pharmacopoeia, they must also comply with the requirements laid down therein. (2) Medicinal products within the meaning of Section 2 (1) of the Medicines Act, which do not comply with the requirements of the Paragraph 1 shall not be placed on the market within the scope of the Medicines Act. Unofficial table of contents

§ 2

(1) According to § 95 (1) No. 2, para. 2 to 4 of the German Medicines Act, the person who intentionally or negligently brings medicinal products to the market in breach of § 1 (2) is punished. (2) According to § 96, point 2 of the German Medicines Act, it is punishable who is contrary to § 1 (1) (1). in the manufacture of medicinal products for colouring purposes other substances or preparations of these substances mentioned therein are used. (3) Anyone who is negligent in committing an act referred to in paragraph 2 shall act in accordance with Section 97 (1) of the German Medicines Act Irregular. Unofficial table of contents

§ 3

(1) This Regulation shall enter into force on the day following the announcement. (2) At the same time, the Ordinance on the Use of Medicinal Products for Medicinal Products shall be adopted on 25 August 1982 (BGBl I). 1237), as last amended by Article 5 of the Law of 27 April 1993 (BGBl I). 512, 2436), except for force. Medicinal products which comply with the Regulation as set out in the first sentence and which is 27. Until 1 November 2006, the marketing authorisation may continue to be placed on the market by pharmaceutical companies and subsequently by wholesalers and retailers until 1 November 2006.