Examples of Directive 2001/83 in a sentence
According to Article 46a (1) of Directive 2001/83 and Article 50a (1) of Directive 2001/82, manufacture includes complete or partial manufacture, import, dividing up, packaging or presentation prior to its incorporation into a medicinal product, including re-packaging or re-labelling as carried out by a distributor.
Attention was also drawn to the distinction made in Directive 2001/83 between “active substances” and “excipients”, the latter being defined as “any constituent of a medical product other than the active substance and the packaging material”.
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.
It is not registered anywhere else in the EU, except in Malta where it is registered under article 126 of Directive 2001/83 of the EU which allows registration for public health reasons.
However, to the extent that the activities in question(2007), health insurance (2007) and physician services (2008) and the Swedish NCA report on consumer welfare in health (2008).242 Case C-62/2009 Association of the British Pharmaceutical Industry v Medicines and Healthcare Products Regulatory Agency [2010] ECR243 Article 94(1) of Directive 2001/83 of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal product for human use (OJ L 311, 28.11.2004, p.
Articles 7 and 8 shall not apply to products authorised under Articles 10, 10a, 13 to 16 or 16a to 16i of Directive 2001/83/ EC.
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.
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.
Europeans Medicines Agency, Guideline on the risk-based approach according to annex I, part IV of Directive 2001/83/ EC applied to advanced therapy medicinal products, 11 February 2013, EMA/CAT/CPWP/686637/2011.