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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. 67–128 (ES, DA, DE, EL, EN, FR, IT, NL, PT, FI, SV)
This document has been published in a special edition(s) ( CS, ET, LV, LT, HU, MT, PL, SK, SL, BG, RO, HR)

OJ L 311, 28.11.2001, p. 67–128

Latest consolidated version:

01/01/2022

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use

OJ L 121, 1.5.2001, p. 34–44 (ES, DA, DE, EL, EN, FR, IT, NL, PT, FI, SV)
This document has been published in a special edition(s) ( CS, ET, LV, LT, HU, MT, PL, SK, SL, BG, RO, HR)

OJ L 121, 1.5.2001, p. 34–44

Latest consolidated version:

01/01/2022

Judgment of the General Court (Seventh Chamber, Extended Composition) of 5 May 2021.
Pharmaceutical Works Polpharma S.A. v European Medicines Agency.
Medicinal products for human use – Application for marketing authorisation for a generic version of the medicinal product Tecfidera – Decision of the EMA not to validate the application for marketing authorisation – Previous decision of the Commission taking the view that Tecfidera – Dimethyl fumarate was not covered by the same global marketing authorisation as Fumaderm – Plea of illegality – Admissibility – Previously authorised combination medicinal product – Subsequent marketing authorisation for a component of the combination medicinal product – Assessment of the existence of two different global marketing authorisations – Manifest error of assessment.
Case T-611/18.

Court reports – general

ECLI identifier: ECLI:EU:T:2021:241

Judgment of the General Court (Sixth Chamber) of 3 March 2010.
Artegodan GmbH v European Commission.
Non-contractual liability - Medicinal products for human use - Decision requiring the withdrawal of marketing authorisations - Annulment of the decision by a judgment of the Court of First Instance - Sufficiently serious breach of a rule of law conferring rights on individuals.
Case T-429/05.

European Court Reports 2010 II-00491

ECLI identifier: ECLI:EU:T:2010:60

Agreement on the European Economic Area - Annex II - Technical Regulations, standards, testing and certification - List provided for in Article 23

OJ L 1, 3.1.1994, p. 263–320 (ES, DA, DE, EL, EN, FR, IT, NL, PT)

OJ L 1, 3.1.1994, p. 263–320

Opinion of Mr Advocate General Mazák delivered on 26 March 2009.
The Queen, on the application of Generics (UK) Ltd v Licensing Authority.
Reference for a preliminary ruling: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court)- United Kingdom.
Reference for a preliminary ruling - Directive 2001/83/EC - Medicinal products for human use - Marketing authorisation - Grounds of refusal - Generic medicinal products - Concept of ‘reference medicinal product’.
Case C-527/07.

European Court Reports 2009 I-05259

ECLI identifier: ECLI:EU:C:2009:197

Judgment of the Court (First Chamber) of 18 June 2009.
The Queen, on the application of Generics (UK) Ltd v Licensing Authority.
Reference for a preliminary ruling: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - United Kingdom.
Reference for a preliminary ruling - Directive 2001/83/EC - Medicinal products for human use - Marketing authorisation - Grounds of refusal - Generic medicinal products - Concept of ‘reference medicinal product’.
Case C-527/07.

European Court Reports 2009 I-05259

ECLI identifier: ECLI:EU:C:2009:379

Opinion of Mr Advocate General Bot delivered on 10 July 2008.
The Queen, on the application of Synthon BV v Licensing Authority of the Department of Health.
Reference for a preliminary ruling: High Court of Justice (England & Wales), Queen’s Bench Division (Administrative Court) - United Kingdom.
Community code relating to medicinal products for human use - Marketing authorisation - Essentially similar medicinal products - Abridged procedure - Procedure for mutual recognition - Grounds for refusal - Liability of a Member State - Serious breach of Community law.
Case C-452/06.

European Court Reports 2008 I-07681

ECLI identifier: ECLI:EU:C:2008:393

Judgment of the Court of First Instance (Fifth Chamber) of 31 January 2006.
Albert Albrecht GmbH & Co. KG and Others v Commission of the European Communities.
Health policy -Veterinary medicinal products - Products containing benzathine benzylpenicillin - Commission decision ordering suspension of marketing authorisations - Competence.
Case T-251/03.

European Court Reports 2006 II-00016*

ECLI identifier: ECLI:EU:T:2006:35

Opinion of Mr Advocate General Jacobs delivered on 16 September 2004.
SmithKline Beecham plc v Lægemiddelstyrelsen.
Reference for a preliminary ruling: Østre Landsret - Denmark.
Medicinal products - Marketing authorisation - Abridged procedure - Essentially similar products - Active substance in different forms of salt - Additional documentation.
Case C-74/03.

European Court Reports 2005 I-00595

ECLI identifier: ECLI:EU:C:2004:541