Losy juranda ze spychowa opowiadanie dzieci

losy juranda ze spychowa opowiadanie dzieci

Labelling as part of the procedures for marketing authorisation Fimea reviews and approves the labelling proposed for a medicinal product as part of the processing of marketing authorisation, variation and renewal applications. Medicine packages or parts thereof can be shared by several countries, the most common version being the Nordic package.

In the centralised procedure, translation of the text proposal labelling approved in the process will suffice. Changes to the labelling Nordic co-operation Medicine packages or parts thereof can be shared by several countries, the most common version being the Nordic package.

losy juranda ze spychowa opowiadanie dzieci

In such a case, the national requirements of each country concerning, for example, the languages used must be taken into account. The instructions for changes in labelling should be followed when submitting the request.

5. Krzyżacy - Opracowanie: Postacie fikcyjne

At least the following information shall usually be printed on the packaging in Finnish and in Swedish: Read more. Changes to the labelling.

losy juranda ze spychowa opowiadanie dzieci

The documents have been drawn up in co-operation between the medicines agencies of Denmark, Finland, Iceland, Norway and Sweden. Package labelling means the markings printed directly onto the immediate or outer packaging or the label of a medicinal product.

losy juranda ze spychowa opowiadanie dzieci

These documents apply to medicinal products intended for both human and veterinary use. The labelling must be based on the QRD template. By using the page, you accept the usage of cookies.

Marketing authorisations

If necessary, labellings can also be changed by submitting a separate 90-day notification. We use cookies to ensure the best user experience. If necessary, marketing authorisation holders can submit questions regarding issues relating to Nordic packages. Fimea reviews and approves the labelling proposed for a medicinal product as part of the processing of marketing authorisation, variation and renewal applications.

losy juranda ze spychowa opowiadanie dzieci

At least the following information shall usually be printed on the packaging in Finnish and in Swedish:. Close navigation. The Guideline on Nordic packages document contains general information on Nordic packages, whereas the Frequently Asked Questions document gives detailed advice on different package issues.