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Directive 75/319/eec

Directive 75/319/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products. This directive of the European Union sought to bring the benefits of innovative pharmaceuticals to patients across. Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products. Official Journal L 147 , 09/06/1975 P. 0013 - 0022. Finnish special edition: Chapter 13 Volume 4 P. 0098 Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products You are here:.. SECOND COUNCIL DIRECTIVE of20 1975May on the approximation of provisions, laid downby law regulation oradministrative action relating to proprietary medicinal products ( ) 75 319/ EEC/ Whereas this Directive represents merely one step towards achievement of theobjective of freethe movement; of proprietary medicinal product

Directive 75/319/EEC - Wikipedi

  1. Directive 75/319/EEC. Directive 75/319/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products. This directive of the European Union sought to bring the benefits of innovative pharmaceuticals.
  2. istrative Action relating to proprietary medicinal products DisplayLogo Publications Office of the European Unio
  3. under Article 12 of Council Directive 1 75/319/EEC of 20 May 1975 SAFETY There is significant concern about the safety of the parenteral infusion of Naftidrofuryl (200mg/10ml), especially with regard to serious cardiovascular and neurological reactions. Th

EUR-Lex - 31975L0319 - EN - EUR-Le

Second Council Directive 75/319/EEC of 20 May 1975 on the

Talk:Directive 75/319/EEC. Jump to navigation Jump to search. WikiProject European Union (Rated Stub-class, Low-importance) This article is within the scope of WikiProject European Union, a collaborative effort to improve the coverage of the European Union on Wikipedia. If you would like to participate, please visit the. Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products(5), Council Directive 89/342/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for immunological medicinal products consisting of vaccines, toxins or serums and. Yes Decision 1999/468/EC Directive 85/374/EEC Directive 98/34/EC Directive 75/319/EEC Directive 81/851/EEC Decision 2010/15/EU Regulation (EEC) No 793/93 Directive 67/548/EEC . Obligations based on CLP hazard class . Yes Within the context of RAPEX, and specifically Annex II (i.e., Procedures for the Application of RAPEX and Guidelines for Notifications) of GPSD, Member States notifying under.

Order of the President of the Court of First Instance of 28 June 2000. Artegodan GmbH v Commission of the European Communities. Procedure for interim relief - Withdrawal of authorisation for medicinal products for human use which contain amfepramon - Directive 75/319/EEC - Urgency - Balancing of interests Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products. DisplayLogo. Publications Office of the European Union. MainSearch . Select. More Advanced search Browse by subject Expert Search. Language Selector. Directive 75/319/EEC, the operation of the procedure Jaid down in chapter III of that Directive (i.e. the multi-state procedure) and its effects on the development of intra-Community trade, thus updating earlier reports3. 2 3 In performing its role as set out in Directive 75/319/EEC, the Committee for Proprietary Medicinal Products (CPMP) gives an opinion as to whether a ·particular.

Artikel 10 Directive 75/319 EEC = dezentrales Verfahren (z.B. Bioverfügbarkeit) Artikel 11 Directive 75/319 EEC = unterschiedliche Entscheidungen Harmonisation of SPC Artikel 12 Directive 75/319 EEC community interest 'Terfenadin', 'Anorektika', Dr. Birka Lehmann 21. und 22. Mai 2001 Die EU-Verfahren einschließlich des Verfahrens der gegenseitigen Anerkennung sind keine. June 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products and laying down special provisions for proprietary medicinal products derived from human blood or human plasma (8), Council Directive 92/25/EEC of 31 March 1992 on the wholesale distribution of medicinal. 75/319/EEC, as last amended by Directive 93/39/EEC. (2) Article 15a of Council Directive 75/319/EEC applies where a Member State considers that the variation of the terms of a marketing authorisation which has been granted in accordance with the Chapter III of Council Directive 75/319/EEC, or its suspension Council Directive 89/342/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for immunological medicinal products consisting of vaccines, toxins or serums and allergens. DisplayLogo. Publications Office of the European Union. MainSearch . Select. More Advanced search Browse by subject Expert Search. Language Selector. BasketSummary.

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  1. Artikel 10 Directive 75/319 EEC = dezentrales Verfahren (z.B. Bioverfügbarkeit) Artikel 11 Directive 75/319 EEC = unterschiedliche Entscheidungen Harmonisation of SPC Artikel 12 Directive 75/319 EEC community interest 'Terfenadin', 'Anorektika'
  2. ology: Adverse reaction means a reaction which is harmful and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or treatment of disease or the modification of physiological function
  3. {6} Text of point 3 (Second Council Directive 75/319/EEC) as amended, deleted by Decision No 82/2002 (OJ L 266, 3.10.2002, p. 32 and EEA Supplement No 49, 3.10.2002, p. 22), e.i.f. 26.6.2002. { 7 } Text of point 4 (Council Directive 78/25/EEC) replaced by Decision No 72/2011 (OJ L 262, 6.10.2011, p. 28 and EEA Supplement No 54
  4. ation of the application
  5. 75/319/EEC (now Article 28 of Directive 2001/83/EC) with the resulting legal consequences. It goes without saying that - as in any other case of mutual recognition - the criteria concerning the CMD(h) Recommendations Extension applications in MRP/DCP July 2006 Page 1/11. CMD(h) Recommendations Extension applications in MRP/DCP July 2006 Page 2/11 identity of the product and the identity.
  6. Laut EU-Regulation 2309/93, Artikel 21 und 22, und EU-Directive 75/319/EEC, Artikel 29c und 29d, müssen pharmazeutische Unternehmer in der EU periodische Berichte erstellen. Das geschieht nach der Neueinführung eines Medikaments zunächst halbjährlich und dann, zwei Jahre nach der Einführung, jährlich mit der Abgabe sogenannter PSUR (Periodic Safety Update Reports). Hier fließen Erkenntnisse aus unterschiedlichen Quellen ein, zum Beispiel aus gemeldeten Neben- oder.

Directive_75/319/EEC - chemeurope

3 Directive 75/319/EEC, Art. 13. 4 Directive 75/319/EEC, Art. 14. 5 Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products [1965-66] OJ English Special Edition p. 24. 6 Joined Cases T74/00, T76/00, T83/00 to T85/00, T132/00, T137/00 and T141/00, Artegodan and Others v Commission. Qualified Person by assessment via the permanent provisions of EU Directive 75/319/EEC; Extensive pharmaceutical manufacturing management and QA experience gained over 20 years working for three major international pharmaceutical manufacturers culminating in the post of Associate Director - Global Audit and Compliance for Wyeth Europa Broad experience with the manufacture of a wide range of. Directive 75/318/EEC and Directive 75/319/EEC were on the approximation of the laws of Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products. These directives of the EU sought to bring the benefits of innovative pharmaceuticals to patients across Europe by introducing the mutual recognition. The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the European Parliament and of the Council) lays down principles and detailed guidelines for good clinical practice as regards conducting clinical trials of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products and laying down additional provisions on homeopathic medicinal products (4) have been frequently and substantially amended. In the interests of clarity and rationality, the said Directives should therefore be codified by assembling them.

The purpose of this Directive is to ensure that products placed on the market are safe. (Art.1) It shall apply to all the products defined in the Article 2 (a) of the Directive. More specifically, a 'product' shall mean any product-including in the context of providing a service-which is intended for consumers or likely, under reasonably foreseeable conditions, to be used by consumers even if not intended for them, and is supplied or made available, whether for consideration or not, in the. A community registration procedure described by Council Directive 75/319/EEC (as amended) for the authorisation of medicinal products. Mutual Recognition Procedure: One of the routes for seeking regulatory approval in the European Union. A submission is first made to a EU Member State authority that assesses, grants a national approval and prepares an assessment report. This report is.

EUR-Lex - 31991L0356 - EN - EUR-Le

  1. istrative action reLating to proprietary medi cinaL products (presented by the Commission to the Counci L) I COM(80) 267 finaL. ~·. • . , . •
  2. The Directive should therefore take account of the special position of trials whose planning does not require particular manufacturing or packaging processes, if these trials are carried out with medicinal products with a marketing authorisation within the meaning of Directive 65/65/EEC, manufactured or imported in accordance with the provisions of Directives 75/ 319/EEC and 91/356/EEC, and on.
  3. -istrative action relating medicinal products,-OJ. Ll.J7 , 09/06/llJ7 5 p. l3 1 . By means ofDirectiv~s 92/73 and 92/74 it was intended to create a legal frame that would allow patients access to the medicinal products of.their choice provided all precautions are taken to.
  4. istrative action relating to medicinal products, Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products, Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid.
  5. istrative action relating to medicinal products.
  6. Article 14: In addition, these guidelines shall lay down adapted provisions relating to labelling for investigational medicinal products intended for clinical trials with the following characteristics: — the planning of the trial does not require particular manufacturing or packaging processes; — the trial is conducted with medicinal products with, in the Member States concerned by the study, a marketing authorisation within the meaning of Directive 65/65/EEC, manufactured or.
  7. istrative action relating to proprietary medicinal products as extended, widened and amended. Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products, as widened and amended. Commission.

EUR-Lex - 31975L0318 - EN - EUR-Le

Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products. This directive of the European Union sought to bring the benefits of innovative pharmaceuticals to patients across Europe by introducing the mutual recognition, by. (c) In the European Community (EC), the qualified person will be relieved of responsibility for carrying the controls laid down in Article 22 paragraph 1(b) of Council Directive 75/319/EEC (see appendix A of this subpart) provided that these controls have been carried out in the United States and that each batch/lot is accompanied by a batch certificate (in accordance with the World Health. Directive 75/319/EEC; Directive 93/41/EEC; Directive 2001/83/EC; Directive 2005/28/EC; Regulation of therapeutic goods; European Medicines Agency; Investigator's Brochure; References. Directive 2001/20/EC of the European Parliament and of the Council. Implementing texts for Directive 2001/20/EC Category: Pharmaceuticals policy : This article is licensed under the GNU Free Documentation License.

EUR-Lex - 32001L0083 - EN - EUR-Le

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 us This Directive supplements Article 19a of Directive 75/319/EEC and deals mainly with personnel, premises and equipment, documentation, production, quality [...] control, complaints and product recall a n d self-inspection

Directive 75/318/EEC - Wikipedi

About: Directive 75/319/EEC - dbpedia

Where a marketing authorisation is granted pursuant to Regulation (EEC) No 2309/93 or when all Member States have granted marketing authorisations according to the procedures for mutual recognition foreseen in Articles 7 and 7a of Directive 65/65/EEC or Article 9(4) of Directive 75/319/EEC in respect o Article 12, Council Directive 75/ 319/ EEC [2] Decisione della Commissione 28 maggio 2004 che dichiara la compatibilità con il mercato comune di una concentrazione [caso N IV/ M. 3396 - Group 4 Falck/Securicor (4064) sulla base del regolamento CEE del Consiglio 4064/89] 29 Thirdly, as regards the objectives pursued by Directive 2003/96, it must be observed, first of all, in accordance with the conditions laid down in Article 23 of the second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products ( 12 ), is responsible in particular for. Does the concept of architect within the meaning of Article 10(c) of the Directive require the migrant to have a university-level education, in accordance with the conditions laid down in Article 23 of the second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products.

Talk:Directive 75/319/EEC - Wikipedi

  1. The Directive 2005/28/EC or Good Clinical Practice Directive, of 8 April 2005 of the European Parliament and of the Council, lays down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products
  2. istrative action relating to proprietary medicinal products (1 ), as last amended by Directive 93/ 39/EEC (2 ), and in particular Article 29i thereof . eur-lex.europa.eu . eur-lex.europa.eu. τη δεύτερη οδηγία 75/319/ΕΟΚ του.
  3. 2. Member States shall take all appropriate measures to ensure that the holder of the authorisation referred to in paragraph 1 has permanently and continuously at his disposal the services of at least one qualified person who, in accordance with the conditions laid down in Article 23 of the second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law.
  4. istrative action relating to proprietary medicinal products as extended, widened..

legislation-profile - ECH

  1. EEC 75/319/EEC Medicinal Products Directive - Also included in volume 65/65/EEC Complete. Directive by European Union Directives, 01/01/1975. View all product details Most Recen
  2. 1. Council Directive 75/319/EEc(*) provides, in Article 15, that the Commission shall report to the Council annually on the operation of the procedure of the Committee for Proprietary Medicinal Products and its effects on the development of intra-Community trade
  3. A complete survey has been made of the amendments to the 75/318/EEC and 75/319/EEC Directives, relating to GMP guidelines, or to the pharmaceutical, toxicological, pharmacological and clinical evaluation of RP's in order to obtain a marketing authorization. This paper will present and discuss the most important EEC drafts relating to RP's. Not only does the RP industry find itself confronted with the new EEC regulation for new RP's, but manufacturers are also obliged to review all.
  4. istrative action relating to proprietary medicinal products (OJ 1975 L 147, p. 13), amended on several occasions, in particular by Directives 83/570 and 93/39 (hereinafter, as amended
  5. Chapters IV and V of Directive 75/319/EEC shall apply to investigational medicinal products. Member States shall permit imports from third States and free distribution within the Member States on condition that there is documentary evidence that the appropriate quality control and product approval has been carried out in a third country in accordance with Paragraph 1

Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products. 1975, Eur-Lex: The Council Of The European Communitie That Codification Directive repealed and re-enacted Council Directive 65/65/EEC (and its successive amendments, namely Council Directives 66/454/EEC, 75/319/EEC, 83/570/EEC, 87/21/EEC, 89/341/EEC, 92/27/EEC and 93/39/EEC); Council Directive 75/318/EEC (and its successive amendments, namely Council Directives 83/570/EEC, 87/19/EEC, 89/341/EEC, 91/507/EEC and 93/39/EEC and Commission Directives. manufacturing or importing authorisation granted in accordance with Article 16 of Directive 75/319/EEC2. Procedures 6. Written procedures should describe the different operations which may affect the quality of the products or of the distribution activity: receipt and checking of deliveries, storage, cleaning an Directives. Directive 65/65/EEC1; Directive 75/318/EEC; Directive 75/319/EEC; Directive 93/41/EEC; Directive 2001/20/EC; Directive 2001/83/EC; Directive 2005/28/EC; See also. European Union law European Union directive European Commission Directorate-General EUR-Lex Regulatory requirement; Regulation of therapeutic good accordance with Article 22 of the Directive 75/319/ EEC (25). Although there is no requirement for the QC manager to hold Qualified Person status in the con- ditions pertaining to U.K. 'specials' manufacturing licences, the Code of Practice for Qualified Persons (26) is widely applicable to QC in the hospital service

EU Regulatory References - BioTechLogic, Inc

CURIA - List of result

Pursuant to Article 11 of Council Directive 75/319/EEC as. publicité. Directives. Directive 65/65/EEC1, requires prior approval for marketing of proprietary medicinal products; Directive 75/318/EEC, clarifies requirements of 65/65/EEC1 and requires member states to enforce them; Directive 75/319/EEC, requires marketing authorization requests to be drawn up only by qualified experts; Directive 93/41/EEC, establishes the European Agency for the Evaluation of. In the EU, the Qualified Person (QP) is no longer responsible for carrying out the controls laid down in Article 22 paragraph 1 (b) of Council Directives 75/319/EEC provided that they have verified these controls have been carried out in the US. Each batch must also be accompanied by a batch certificate issued by the manufacturer and signed by the person responsible for releasing the batch The Second Council Directive (75/319/EEC) of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, as amended by Directive 93/39, provides for a number of arbitration procedures before the Committee for Proprietary Medicinal Products ('the CPMP') of the European Agency for the Evaluation of Medicinal Products

A person engaging in the activities of the person referred to in Article 48 from the time of the application of Directive 75/319/EEC, in a Member State without complying with the provisions of Article 49 shall be eligible to continue to engage in those activities [F1 within the Community]. 2. The holder of a diploma, certificate or other evidence of formal qualifications awarded on completion. The particulars to appear in at least the official language(s) of the Member State on the outer packaging of investigational medicinal products or, where there is no outer packaging, on the immediate packaging, shall be published by the Commission in the good manufacturing practice guidelines on investigational medicinal products adopted in accordance with Article 19a of Directive 75/319/EEC

Council Directive 75/318/EEC of 20 May 1975 on 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. The Directive dealt with the disparities between certain national provisions, in particular between provisions relating to medicinal products, which directly affected the functioning of the internal market of the European Union •Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products, as amended by: Council Directive 78/420/EEC Council Directive 83/570/EEC Council Directive 89/341/EEC Council Directive 92/27/EEC Council Directive 93/39/EEC Commission Directive 2000/38 /EC IMBNEWSLETTER 4 •Council Directive. © Pharmaceutical Consultancy Services, All rights reserved. General Introduction to GMP, History, ICH, PIC/S, EU, FD

Member States shall take all appropriate measures to ensure that the holder of the authorisation referred to in paragraph 1 has permanently and continuously at his disposal the services of at least one qualified person who, in accordance with the conditions laid down in Article 23 of the second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products ( 12 ), is responsible. Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products DisplayLogo Publications Office of the European Unio

Directive_75/319/EEC : définition de Directive_75/319/EEC

Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law' regulation or administrative action relating to proprietary medicinal productsS, Council Directive 89/342/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for immunological medicinal products consisting of vaccines, toxins or serums. Pharmaceuticals Policy and Law 7 (2005,2006) 285â 289 IOS Press Council Directive 89/381/EEC of 14 June 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products and laying down special provisions for medicinal products derived from human blood or human.

Council Directive 89/342/EEC of 3 May 1989 extending the

Article 4 — Medicinal products for human use covered by the procedures laid down in Directive 2001/83/EC; Article 5; Article 6 — Veterinary medicinal products covered by the procedures laid down in Directive 2001/82/EC; Article 7; Article 8 — Various Fees; Article 9 — Possible fee reductions; Article 10 — Due date and deferral of the paymen Directive 65/65/EEC, manufactured or imported in accordance with the pro-visions of Directives 75/319/EEC and 91/356/EEC, and on patients with the same characteristics as those covered by the indication specified in this mar-keting authorisation. Labelling of the investigational medicinal products inten-ded for trials of this nature shoul Directive 75/319/EEC. 100% (1/1) EudraLex Directive 75/318/EEC Directive 2001/83/EC Directive 93/41/EEC Regulation of therapeutic goods. Good Clinical Practice Directive. 100% (1/1) Directive 2005/28/EC. Ethics committee (European Union) EudraLex Clinical Trials Directive Regulation of therapeutic goods Good clinical practice. Directive 2001/83/EC . 100% (1/1) Directive. EudraLex Directive 75. referred to in Article 17 of Directive 75/319/EEC and Article 29 of Directive 81/851/EEC, and in Sections 4 and 19 of Act 79/1997 Coll. eur-lex.europa.eu D i e Bescheinigung w ird von de r für di e Freigabe de r Charge z ur A us fuhr verantwortlichen Person unterzeichnet, [...

Directive 2001/20/EC or Clinical Trials Directive of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, Regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.. This Directive aims at facilitating the internal market in. Whereas the approximation of laws brought about in this connection must enable a proprietary product, manufactured and marketed in one Member State on the basis of harmonized provisions, to be allowed into another Member State, taking into due consideration the initial authorization, save in exceptional cases submitted for an opinion to the Committee for Proprietary Medicinal Products set up by Directive 75/319/EEC Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation, and administrative action relating to medicinal products15, and by Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of medicinal. 19 AMG und gemäß Annex 16 zur EU GMP-Richtlinie (Council Directive 75/319/EEC) Main Responsibilities And Accountabilities. Sachkundige Person gemäß ; 14 AMG (Qualified Person gemäß Annex 16 der EU GMP-Richtlinie) mit der erforderlichen Sachkenntnis nach ; 15 AMG, die gemäß ; 19 AMG dafür verantwortlich ist, dass jede Charge eines Arzneimittels entsprechend den Vorschriften über den. Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products as extended, widened and amended. Council Directive 81/851/EEC of 6 November 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products as widened and amended. Commission.

Adverse Drug Reactions Databas

Chapter III) and Council Directive 75/319/EEC as amended (Chapter Va) [25]. The obligations apply to all authorised medicinal products, are clarified in the draft-Notice to Marketing Authorisation Holders and incorporate among other things that the design of company sponsored postmarketing surveillance studies will depend on the objectives of the study, which must be clearly defined in the. Commission 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 (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Directive 2001/83/EC.

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