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Council Directive 65/65/EEC of 26 January 1965 on the .... Directive 65/65/EEC s. However, where the medicinal product is intended for a different ...

http://www.echamp.eu/fileadmin/user_upload/Regulation/Directive_65-65-EEC__-__Consolidated_Version.pdf

Whereas the approximation begun by Council Directive 65/65/EEC (3) of 26 ... in accordance with Article 4 of Directive 65/65/EEC, whether the patient ...

http://www.echamp.eu/fileadmin/user_upload/Regulation/Directive_75-319-EEC__-__Consolidated_Version.pdf

An applicant wishing to use Article 4.8 (a)ii) of Directive 65/65/EEC must fully satisfy all the requirements of Article 1 of Directive 75/318/EEC as well ...

http://www.emea.europa.eu/pdfs/human/hmpc/000699en.pdf

second paragraph, of Directive 65/65/EEC, references to published data are ... botanical drugs without being subject to Council Directive 65/65/EEC. ...

http://www.emea.europa.eu/pdfs/human/hmpc/002399en.pdf

Directive 89/342/EEC s. Article 3. In addition to the information referred to in Article 4a of Directive 65/65/EEC the summary of ...

http://www.weesgeneesmiddelen.nl/websites/wgm/files/4 Regelgeving 89342en.pdf

The authorization referred to in Article 3 of Directive 65/65/EEC shall be ... Without prejudice to Article 8 of Directive 65/65/EEC and Article 6 of ...

http://www.ikev.org/docs/eu/389L0343.pdf

Whereas Council Directive 65/65/EEC of 26 January 1965 on the approximation of .... characteristics referred to in Article 4b of Directive 65/65/EEC. ...

http://www.ikev.org/docs/eu/392L0027.pdf

of Directive 65/65/EEC or Article 5a of Directive 81/851/EEC;. (c) if the authorization referred to in (b) is not the first authorization ...

http://www.upv.cz/dms/pdf_dokumenty/eurostranky/spc/01992r1768-20040501-en_cs/01992R1768-20040501-EN_CS.PDF

Dir 65/65 EEC - Framework Directive designed to .... Article 1 of Directive 65/65 EEC (now codified in Directive 2001/83 Defines ...

http://www.nihs.go.jp/dbcb/Biologics_forum/Bioforum-0/0-Morrison.pdf

Whereas the approximation begun by Council Directive 65/65/EEC (1) of 26 ... second paragraph, of Directive 65/65/EEC are closely related to points 3, 4, ...

http://www.ivaa.info/userfiles/file/75_318_EEC.pdf

principles of Directive 65/65/EEC apply to any homoeopathic medicinal .... Directive 65/65/EEC relating to Medicinal Products and related. Directives ...

http://www.fsai.ie/uploadedFiles/6342926_guidelines.pdf

9 Apr 2003 ... application in accordance with Art. 4.8. (a) ii of Directive 65/65/EEC". Bundesverband der Arzneimittel-Hersteller e.V. ...

http://www.ga-online.org/files/kiel2003/Steinhoff WS Kiel.pdf

amending Annex A to Council Directive 92/65/EEC to include the small hive beetle (Aethina tumida), the Tropilaelaps mite (Tropilaelaps spp. ...

http://faolex.fao.org/docs/pdf/eur39157.pdf

of the requirements of Article 6 of Directive 92/65/EEC.' Article 7 ..... 'Council Directive 92/65/EEC of 13 July 1992 laying down animal ...

http://eur-lex.europa.eu/LexUriServ/site/en/consleg/1992/L/01992L0065-20040703-en.pdf

26 Nov 2009 ... of Directive 65/65/EEC?!? - Reality? - Before accession the dossiers were not re- evaluated according the provisions of the. 65/65/EEC due ...

http://www.basg.at/uploads/media/091126_EU_Konformitaet.pdf

in well with the framework provided by Directive 93/65/EEC. .... be transposed into national legislation, unless Directive 93/65/EEC had been ...

http://aei.pitt.edu/5975/01/003183_1.pdf

governed by Directive 65/65/EEC; whereas a distinction must be drawn .... Article 1 of Directive 65/65/EEC, that substance sha Irbe subject to the ...

http://aei.pitt.edu/8926/01/31735055279032_1.pdf

summary of the product characteristics listed in Article 4a of Directive 65/65/EEC or Article 5a of. Directive 81/851/EEC; ...

http://www.wipo.int/clea/docs_new/pdf/en/gr/gr011en.pdf

exclusivity is laid down in Directive 65/65/EEC as amended by Directive 87/21/EEC. The same regulation granting exclusivity to the original product is used ...

http://www.wipo.int/edocs/mdocs/ip-conf-bg/en/wipo_ectk_sof_01/wipo_ectk_sof_01_2_5.pdf

products in Council Directive 87/21/EEC, which revised Article 4.8 of. Directive 65/65/EEC, exempts generic companies from providing the ...

http://assets.cambridge.org/97805217/92493/excerpt/9780521792493_excerpt.pdf

Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by ... of Directive 65/65/EEC references to published data are ...

http://www.rivendell.eu/library/documents/wetten engels/herbal products/1999-83-EC (Eng).pdf

been granted in accordance with Directive 65/65/EEC or Directive 81/851/EEC, as ... Article 4a of Directive 65/65/EEC or Article 5a of Directive 81/851/EEC; ...

http://www.cabrnoch.cz/media/EEC1768-92.pdf

within the meaning of Council Directive 65/65/EEC and Council Directive. 92/73/EEC. These instruments have now been repealed by Directive ...

http://www.governmentchemist.org.uk/dm_documents/Classification of supplements as food or medicinal products_gZ1kQ.pdf

Directive 65/65/EEC” there is substituted “Article 1.2 of the 2001 Directive”, ..... repealed and re-enacted Council Directive 65/65/EEC (and its successive ...

https://opsi.gov.uk/si/si2002/uksi_20020236_en.pdf

Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid .... Article 1 of Directive 65/65/EEC, in particular relating to the ...

http://www.eortc.be/Services/Doc/clinical-EU-directive-04-April-01.pdf

Directive 65/65/EEC, that the constituent(s) of a medicinal product have a well established use, with an acceptable level of safety, the ...

http://www.bfarm.de/nn_1198988/SharedDocs/Publikationen/DE/Arzneimittel/2__zulassung/zulArten/bes-therap/allgemeines/escopbonn2001,templateId=raw,property=publicationFile.pdf/escopbonn2001.pdf

section E of the Annex to Directive 75/318/EEC as amended and Article 4,2 point 8 of Directive 65/65/EEC as amended with a view to the granting of a ...

http://www.seoho.biz/GMP_Quick_Search/Data/2. European Documents/2.13.15.pdf

7 Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to ...

http://www.seoho.biz/GMP_Quick_Search/Data/2. European Documents/2.5.13.pdf

Within the European Union a medicine is defined in Directive 65 / 65 EEC as: (a) any substance or combination of substances presented for treatment or ...

http://www.rpsgb.org.uk/pdfs/scireportcompmedapp.pdf

According to Article 3 of Directive 65/65/EEC no medicinal product may be ... Article 24 of Directive 65/65/EEC and Article 34 of Directive 75/319/EEC pro- ...

http://iospress.metapress.com/index/940H1FB3TXHU46HX.pdf

Directive 65/65/EEC [3] was one of the first European legislations that were adopted ... Directive 65/65/EEC had a limited scope: it was only applicable to ...

http://iospress.metapress.com/index/407KR4T372HJH93P.pdf

Directive 65/65/EEC is the basis for all pharmaceutical regulations. It includes relevant definitions (medicinal product, proprietary medicinal product, ...

http://pdfs.journals.lww.com/nuclearmedicinecomm/2001/01000/12.pdf

Directive 65/65/EEC [10.1 (a) (ii) of Directive 2001/83/EC]. The scientific literature demonstrated that the active substance in Phenoxymethylpenicillin 250 ...

http://www.mhra.gov.uk/home/groups/l-unit1/documents/websiteresources/con2023572.pdf

All applications were made under the Directive 65/65/EEC. 1. PL 00327/0146 Nurofen Tablets - Article 4.8 FULL. 2. PL 00327/0145 Nurofen Caplets - Article ...

http://www.mhra.gov.uk/home/groups/es-foi/documents/foidisclosure/con2031097.pdf

Rome and the Directives 65/ 65/ EEC1 and. 75/318/EEC2 as amended by Directive 91/ 507/. EEC with the Commission as the governing institution. ...

http://ard.bmj.com/content/58/suppl_1/I92.full.pdf

Directive 2001/83/EC (then Directive 65/65/EEC) – Generic applicants. Case C-223/01 – AstraZeneca A/S v Laegemiddelstyrelsen,. Generics (UK) Intervening ...

http://www.pharmalaw-events.com/presentations/2007/05 - Gerry Kamstra.pdf

by RF KINGHAM - Cited by 9

http://www.fdli.org/pubs/Journal Online/55_2/art3.pdf

2. For the purpose of implementing Amele 8 oí Directive 65/65/EEC and. Article 21 oí Directive 75/319/EEC. Member States may require manufacturers of ...

http://www.scotblood.scot.nhs.uk/site/pubdocs/THE COUNCIL OF THE EUROPEAN COMMUNITIES AUGUST 1990.pdf

Directive 65/65/EEC or Directive 81/851/EEC, as appropriate;. • (c) the product has not already been the subject of a certificate; ...

http://www.conopa.com/Files/Powerpoint/9SPC_CONOPA_foredrag_29082008.pdf

(1) Council Directive 65/65/EEC of 26 January 1965 on the approximation of .... a marketing authorisation within the meaning of Directive 65/65/EEC, ...

http://www.vib.be/NR/rdonlyres/1066CDE0-9C11-476B-B44E-18BCEDCA50A7/0/GCPrichtlijn2001_20_EC.pdf

(1) Council Directive 65/65/EEC of 26 January 1965 on the .... Article 1 of Directive 65/65/EEC, in particular relating to the ...

http://oss-sper-clin.agenziafarmaco.it/normativa/direttiva_europea_ing.pdf

use, as defined in Article 2 of Directive 65/65/EEC;. (b) 'orphan medicinal product' means a medicinal product designated as such under the terms and ...

http://www.ebe-biopharma.org/documents/omp/orphanreg2000-141.pdf

was in respect of human use only under Directive 65/65/EEC, and the first ... Directive 65/65/EEC, then the first authorization in the Community for the ...

http://rpc.oxfordjournals.org/cgi/reprint/113/4/111.pdf

document did not appear to have been granted under Directive 65/65/EEC or ... the first authorization in accordance with Directive 65/65/EEC or ...

http://rpc.oxfordjournals.org/cgi/reprint/114/3/118.pdf

harmonised by Directive 65/65/EEC and are now set out in Directive 2001/83 (as amended). .... Directive 65/65/EEC? It is understood that the judgment is now ...

http://www.twobirds.com/English/Publications/NewsLetters/Upload/LifeSciencesJuly2009.pdf

'(c) medicinal products covered by Directive 65/65/EEC, including medicinal products derived from blood as covered by Directive 89/381/EEC;'; ...

http://www.mdt-gmbh.com/cms/images/stories/pdf_dateien/european_documents/05.pdf

For the purposes of this Directive, the definition of medicinal products set out in Article 1 (2) of. Council Directive 65/65/EEC ,(3) and the definition of ...

http://www.zlg.nrw.de/download/AM/rechtsquellen/eg/RL_1991_412_EN.pdf

granted in accordance with Directive 65/65/EEC or Directive 81/851/EEC. However, in the case of the products discussed there are no authorizations for their ...

http://www.wtspatent.pl/files/en5.pdf

This guideline should be read in conjunction with Directive 65/65/EEC as amended, the. Notice to Applicants and, where relevant, the note for guidance on ...

http://www.tga.gov.au/docs/pdf/euguide/vol3c/3cc12aen.pdf

87/21/EEC Directive28, which amended the 65/65/EEC Directive. ... 26 Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid ...

http://www.cptech.org/publications/CPTechDPNo1TestData.pdf