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English to Serbian translations [PRO]
Medical - Medical: Pharmaceuticals / veterinary medical products | | English term or phrase: the homeopathic stock | The Latin name of the homeopathic stock described in the marketing authorisation application dossier shall be in accordance with the Latin title of the European Pharmacopoeia or, in absence thereof, of an official pharmacopoeia of a Member State.
The particulars and documents on the starting materials, i.e. all of the materials used including raw materials and intermediates up to the final dilution to be incorporated into the finished homeopathic veterinary medicinal product, accompanying the application shall be supplemented by additional data on the homeopathic stock. |
| | | matična homeopatska sirovina | Explanation:
U Pravilniku o načinu obeležavanja spoljašnjeg i unutrašnjeg pakovanja ALIMS-a stoji:
Spoljnje pakovanje leka i uputstvo za pacijenta - korisnika iz stava 1. ovog člana sadrži sledeće podatke:
1) naziv matične homeopatske sirovine (stok), stepen razblaženja sa oznakama evropske farmakopeje i nacionalne farmakopeje (ako homeopatski lek sadrži dva ili više stoka, naučno ime stoka može se zameniti zaštićenim imenom);
U Pravilniku istog naziva iz 2011. godine stoji:
Спољње паковање хомеопатског лека и упутство за хомеопатски лек мора бити обележено натписом: "Хомеопатски лек".
Спољње паковање лека и упутство за лек из става 1. овог члана садрже следеће податке:
1) назив матичне хомеопатске сировине, степен разблажења са ознакама европске фармакопеје и националне фармакопеје (ако хомеопатски лек садржи две или више хомеопатске сировине, научно име хомеопатске сировине се може заменити заштићеним именом);
Dakle, očigledno se više ne upotrebljava reč "stok" već samo "matična homeopatska sirovina".
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Note added at 48 mins (2011-12-10 09:58:38 GMT)
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Ispravka, prvi citat je iz pravilnika iz 2008. godine. |
| Selected response from:
  Katarina Delic
Serbia
Local time: 16:57
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