Dye Regulation

Original Language Title: Arzneimittelfarbstoffverordnung

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$40 per month, or Get a Day Pass for only USD$9.99.

Drug Dye Ordinance (AMFarbV)

Non-official table of contents

AMColorV

Date of delivery: 17.10.2005

Full quote:

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

:modified by Art. 8 G v. 17.7.2009 I 1990

For details, see the menu under Notes
This regulation is used for the implementation of the
-
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, 28.12.2001, 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 327, 28.12.2001, p. EC No L 311 p. 67).

Footnote

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

unofficial table of contents

input formula

It reassorted
-
the Federal Ministry of Health and Social Protection on the basis of § 6 (1) sentence 1 and § 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 June 2003. 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 Article 83 (1) and (2) of the Medicinal Products Act, as amended by the 11. December 1998 (BGBl. 3586), of which Article 6 (1) was last amended by Article 1 (4) (a) of the Law of 30 June 2003. July 2004 (BGBl. 2031), in agreement with the Federal Ministry of Health and Social Protection:
Non-official table of contents

§ 1 

(1) In the manufacture of medicinal products within the meaning of Article 2 (1) of the Medicines Act, which are intended to be used in a Member State of the European Communities or in another State Party to the Agreement on European 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 May be allowed to be placed on the market. The European Parliament and the Council of the European Union (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 the 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 set out therein.(2) Medicinal products within the meaning of Section 2 (1) of the Medicines Act, which are not manufactured in accordance with the provisions of paragraph 1, may not be placed on the market within the scope of the Medicines Act. Non-official table of contents

§ 2

(1) According to § 95, para. 1, no. 2, para. 2 to 4 of the Medicines Act, it is punished who intentionally or negligently Placing the medicinal product on the market in accordance with § 1 (2).(2) In accordance with Section 96 (2) of the Medicines Act, it shall be punished who, contrary to § 1 (1), is used in the manufacture of medicinal products for colouring purposes other than the substances or preparations mentioned therein from these substances.(3) Anyone who is negligent in committing an act referred to in paragraph 2 shall act in an orderly way in accordance with Section 97 (1) of the Medicinal Products Act. Non-official table of contents

§ 3

(1) This Regulation will enter into force the day after the announcement.(2) At the same time, the Ordinance on Medicinal Products for Dye Substances August 1982 (BGBl. 1237), as last amended by Article 5 of the Law of 27. April 1993 (BGBl. 512, 2436), except for force. Medicinal products which comply with the Regulation as set out in the first sentence and which is 27. The European Parliament and the Council of the European Union, which are on the market in October 2005 It will continue to be placed on the market by pharmaceutical companies and subsequently by wholesalers and retailers.