Directive 2001/83 definition

Directive 2001/83 means Directive 2001/83/EC of the European Parliament and of the Council of 6th November 2001 on the Community Code relating to medicinal products for human use(6);

Directive 2001/83 means Directive 2001/83/EC of the European Parliament and of the Council of 6th November 2001 on the Community Code relating to medicinal products for human use F12[F13as 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

Directive 2001/83 means Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use (and any implementing, amended and/or successor legislation applicable to the UK or any part of it);

Examples of Directive 2001/83 in a sentence

• For recommendations to the marketing authorisation not falling under Article 21a/22 of Directive 2001/83 and conditions to the marketing authorisation pursuant to Article 21a or 22 of Directive 2001/83/EC to the marketing authorisation, please see section VI.

• In addition, it is of course beyond discussion that the four cases mentioned in the Code of Conduct (sub-section 5.1.2) or the Medicines Act (and Directive 2001/83) respectively, to which the Code of Conduct or the Medicines Act (and the Directive) respectively do not apply, must at any rate be considered as information.

• Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with ►M5 Article 114(2) of Directive 2001/83/ EC ◄.ANNEX III EC TYPE-EXAMINATION ▼M5 ▼B1.

• Nor, on this approach, was there is any inconsistency between Novartis and Synthon, since the adaptation provided that a Swiss marketing authorisation recognised in Liechtenstein was to be treated as an authorisation in accordance with Directive 2001/83.

• The application is being made under Article 10(a) of Directive 2001/83 as amended, and accordingly no additional toxicological, pharmacological or clinical efficacy studies have been performed.

• This application is being made under Article 10(a) of Directive 2001/83 as amended, and accordingly no additional toxicological, pharmacological or clinical efficacy studies have been performed.

• Pcy "as defined in" is a more appropriate legal drafting in point (b) since some medicinal products are excluded from Directive 2001/83, by virtue of Art.

• However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83 and published on the European medicines web-portal.

• The application was submitted under Article 16a traditional use registration for herbal medicinal products of the Directive 2001/83 EC, as amended.

• Therefore, the Authority concludes that the method of classifying medicinal products in Norway in this regard is in accordance with Article 1(2) of Directive 2001/83.

More Definitions of Directive 2001/83

Directive 2001/83 means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use(9) as last amended by Directive 2009/53/EC of the European Parliament and of the Council amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products(10);

Directive 2001/83 means Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use (and any implementing, amended and/or successor legislation applicable to the UK or any part of it); “Directive 2003/94” means Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (and any implementing, amended and/or successor legislation applicable to the UK or any part of it);