Voorbeelden van het gebruik van Marketing authorization in het Engels en hun vertalingen in het Nederlands
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Veterinary use- Marketing authorization.
Marketing authorization with orphan designation.
Name of the holder of the marketing authorization.
Marketing authorization Holder BioMarin Europe Limited,
Hightechnology medicinal products: marketing authorization 5.2.
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The marketing authorization holder shall be required to maintain records of all adverse reactions observed in animals or human beings.
New instructions for the submission of an application for renewing a marketing authorization-- FAMHP.
Where to find the marketing authorization or registration number?
The required dose including Justified limits will be stated In the marketing authorization for the product.
The marketing authorization holder shall be notified of the results of the examination within the same time-limit.
Tetrazepam-containing medicines: suspension of the marketing authorization and withdrawal from the market.
By virtue of Regulation(EC) No 2309/93, certain medicinal products are the subject of a Community marketing authorization.
Applications for registration or for marketing authorization for produas covered by this Direaive lodged.
medicinal products without marketing authorization is therefore illegal in the EU.
The transfer of a marketing authorization shall not affect any of the time limits provided for in Articles 13 and 35 of Regulation(EC) No 2309/93.
Annex II- Authorizations and proposed conditions of the marketing authorization for the medicinal product GONAL F®.
The holder of the marketing authorization shall notify the dates on which the dossiers were sent to the Member States concerned.
Descovy is Gilead's second TAF-based therapy to receive marketing authorization in the European Union.
The Member States and the marketing authorization holder shall forward to the Committee all available information relating to the matter in question.
The competent authorities of the Member States shall suspend or withdraw marketing authorization when it is clear that.
If a marketing authorization were to be issued by the MCA,
it has renewed the marketing authorization for Phentermine pills again.
Marketing authorization has been granted in France for the medicinal product with the trade name RU 486, in accordance with the Community regulations governing medicinal products.
The routine tests carried out on each batch of starting materials must be as stated in the application for marketing authorization.
The same shall apply where one or more Member States have suspended or withdrawn marketing authorization while one or more of the other Member States have not done so.
The marketing authorization holder shall have permanently
The Commission is only able to intervene directly for medicinal products that have received a Community marketing authorization through the centralized procedure.
Sun holds a marketing authorization for generic zoledronate 5 mg/100 ml for the treatment of both osteoporosis
This report notes that the two Community procedures are favourably received by the pharmaceutical industry with an increasing number of applications for marketing authorization submitted.
Such marketing authorization should also be refused where the withdrawal period indicated is not long enough to eliminate health hazards arising from residues.