Примери за използване на Marketing authorization на Английски и техните преводи на Български
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Colloquial
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Official
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Medicine
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Ecclesiastic
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Ecclesiastic
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Computer
Marketing authorization holder.
(i) mentions that the medicinal product has been granted a marketing authorization.
Marketing Authorization for Pizona.
Name or corporate name andpermanent address of the marketing authorization holder.
Marketing Authorization Holder and Manufacturer.
Хората също превеждат
Lidocaine-Tchaikapharma is the company's newest product with a marketing authorization issued by BDA.
Marketing authorization may be granted on the following conditions.
Pemetrexed-Tchaikapharma is the newest oncological product of the company with a Marketing Authorization.
A marketing authorization should be suspended, varied or withdrawn.
The studies presented at renewals of marketing authorization in EU were also screened and reviewed.
A marketing authorization may only be granted to an applicant established in the Community.
Lidocaine-Tchaikapharma is the company's newest product with a marketing authorization issued by BDA| TchaikaPharma.
The marketing authorization holder shall make arrangements for archiving of documentation.
Pemetrexed-Tchaikapharma is the newest oncological product of the company with a Marketing Authorization| TchaikaPharma.
A marketing authorization may be granted only to an applicant established in the EU.
The routine tests carried out on each batch of starting materials must be as stated in the application for marketing authorization.
A marketing authorization may only be granted to an applicant established in the Community.
In addition, by virtue of Regulation(EC)No 2309/93, certain medicinal products are the subject of a Community marketing authorization.
Marketing authorization may be granted only to an applicant established in the European Union.
The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an European Union-wide marketing authorization.
The clinical trials before marketing authorization have been performed up to a BMI equal to 40 kg/m.
The CHMP was therefore of the view that the risk benefit ratio of Galantamine STADA is negative and that a marketing authorization should not be granted.
When a marketing authorization is granted, the competent authorities shall specify the classification of the medicinal product into.
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.
The application for marketing authorization shall list those tests which are carried out on representative samples of each batch of finished product.
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.
Marketing authorization should be refused where a medicinal product lacks therapeutic effect or where there is insufficient proof of such effect.
In the event of a draft decision which envisages the granting of marketing authorization, the documents referred to in Article 32(5)(a) and(b) shall be annexed.
The marketing authorization may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance by the EMA or by the competent authority of the EU Member State.
The particulars and documents which must accompany applications for marketing authorization, pursuant to point 3 of Article 8(3)(c) shall be submitted in accordance with the following requirements.