Примери за използване на Marketing authorization на Английски и техните преводи на Български
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A decision as referred to in paragraph 1 shall be addressed to the Member States concerned by the matter and reported to the marketing authorization holder.
Marketing authorization should be refused where a medicinal product lacks therapeutic effect
The routine tests carried out on each batch of starting materials must be as stated in the application for marketing authorization.
20 mg solution for injection is Tchaikapharma's newest product which has obtained a Marketing Authorization issued by the Bulgarian Drug Agency. Therapeutic indicatio.
To protect patients' health, EMA is recommending immediate suspension of the medicine's marketing authorization in the EU and a recall of batches from pharmacies and hospitals.
are to be treated, as regards registration and marketing authorization, in the same way as homeopathic medicinal products.
A marketing authorization may only be granted to an applicant established in the Community.
No 2309/93, certain medicinal products are the subject of a Community marketing authorization.
Pemetrexed-Tchaikapharma is the newest oncological product of the company with a Marketing Authorization| TchaikaPharma.
The studies presented at renewals of marketing authorization in EU were also screened and reviewed.
batches produced according to the manufacturing process described in the application for marketing authorization.
These may result in evidential uncertainty at the time of the marketing authorization.
the dossier of the product is prepared to serve the purposes of Marketing Authorization Application.
In the event of a favorable opinion on the marketing authorization renewal procedure, they are going
The routine tests carried out on each batch of starting materials must be as stated in the application for marketing authorization.
Adverse reactions may arise from the use of the product within or outside the terms of marketing authorization or from occupational exposure.
batches produced according to the manufacturing process described in the application for marketing authorization.
In the event of a favorable opinion on the marketing authorization renewal procedure, they are going to be added to the list.
batches produced according to the manufacturing process described in the application for marketing authorization.
such product is used in accordance with the terms of the marketing authorization;