Convention for the Mutual Recognition of Inspections in ... - PIC/S

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CONVENTIONFOR THE MUTUALRECOGNITIONOF INSPECTIONSIN RESPECT OF THEMANUFACTUREOF PHARMACEUTICALPRODUCTSCONVENTION POURLA RECONNAISSANCEMUTUELLEDES INSPECTIONSCONCERNANTLA FABRICATIONDES PRODUITSPHARMACEUTIQUESPublished in October 1970byTHE EUROPEANFREE TRADE ASSOCIATION9-11, rue de Varembé - GenevaPublié en octobre 1970parl’ASSOCIATION EUROPÉENNEDE LIBRE-ÉCHANGE9-11, rue de Varembé - Geneva
CONVENTIONFOR THE MUTUALRECOGNITIONOF INSPECTIONSIN RESPECT OF THEMANUFACTUREOF PHARMACEUTICALPRODUCTSCONVENTION POURLA RECONNAISSANCEMUTUELLEDES INSPECTIONSCONCERNANTLA FABRICATIONDES PRODUITSPHARMACEUTIQUES(and Explanatory Notes)(et Notes explicatives)PREAMBLEThe Republic of Austria, the Kingdom ofDenmark, the Republic of Finland, theRepublic of Iceland, the Principality ofLiechtenstein, the Kingdom of Norway, thePortuguese Republic, the Kingdom ofSweden, the Swiss Confederation and theUnited Kingdom of Great Britain andNorthern Ireland:Considering that in the interest of publichealth pharmaceutical products whetherexported or not should be producedaccording to appropriate standards;Considering that the rapid development ofnew drugs, especially complex syntheticsubstances of great pharmacologicalpotency, necessitates strict quality controlof their manufacture;Considering that official inspection isnecessary to ensure such manufacturingcontrol;PRÉAMBULELa République d’Grande-Bretagne, leRoyaume de Danemark, la République deFinlande, la République d’Islande, laPrincipauté de Liechtenstein, le Royaume deNorvège, la République Portugaise, leRoyaume de Suède, la Confédération Suisseet le Grande-Bretagne de Grande-Bretagneet d’Irlandc du Nord,Considérant que dans 1’intérêt de la santépublique, les produits pharmaceutiques,qu’ils soient exportés ou non, devraientêtre fabriqués selon des normes appropriées;Considérant que 1’apparition rapide denouveaux remèdes, notamment desubstances synthétiques complexes àgrande puissance pharmacologique, exigeun strict contrôle de la qualité de leurfabrication;Considérant qu’une inspection officielleest nécessaire pour assurer pareil contrôlede la fabrication;3
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Page 5 and 6: ARTICLE 2 ARTICLE 21. Upon the requ
Page 7: PART IICHAPITRE IIInspectionsInspec
Page 10 and 11: 2. The depositary Government shalls
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Page 15 and 16: Article 2 Article 27. Information i
Page 17 and 18: Article 3 Article 312. Paragraph 1
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Page 21 and 22: inspections shall be currently exch
Page 23: Article 8 and by a reciprocal invit

Convention for the Mutual Recognition of Inspections in ... - PIC/S

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