Koninklijk besluit tot wijziging van het koninklijk besluit van 6 juni 1960 betreffende de fabricage, distributie in het groot en de terhandstelling van geneesmiddelen., de 7 août 1995
Artikel 1. Artikel 15, 2°, van het koninklijk besluit van 6 juni 1960 betreffende de fabricage, distributie in het groot en de terhandstelling van geneesmiddelen, gewijzigd bij de koninklijke besluiten van 5 november 1985 en 31 december 1992 wordt aangevuld met de volgende leden :
" Anderzijds worden voor de produkten vermeld in artikel 1, 1°, tweede lid, d), e), f) en g) die ingevoerd zijn vanuit een andere Lid-Staat van de Europese Gemeenschap, de vergunninghouders vrijgesteld van de controles bedoeld in het eerste lid wanneer de ingevoerde partijen vergezeld zijn van de controleverslagen ondertekend door een in de Lid-Staat van oorsprong hiertoe bevoegd persoon waarvan de kwalificatie erkend en geattesteerd is door de bevoegde overheden van dat land.
De nodige bewijsstukken en getuigschriften dienen door de vergunninghouder ter beschikking gehouden te worden van de farmaceutische inspecteurs. Ze zullen een model van de conform verklaarde handtekening van de bevoegde persoon bevatten. "
Art. 2. Dit besluit treedt in werking de dag waarop het in het Belgisch Staatsblad wordt bekendgemaakt.
Art. 3. Onze Minister van Volksgezondheid en Pensioenen is belast met de uitvoering van dit besluit.
Gegeven te Châteauneuf-de-Grasse, 7 augustus 1995.
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