Примери за използване на Holder of the 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
It has received a reasoned request by the holder of the authorization.
Minister of Health shall notify the holder of the authorization.
Does not exempt the holder of the authorization for use of the requirement of art.
(2) The customs authorities may extend the period under Paragraph 1 on submission of a duly substantiated request by the holder of the authorization.
Any other local person,who has obtained the agreement of the holder of the authorization and if the condition of the authorization is met.
If he personally fulfils the conditions laid down in Article 53, the holder of the authorization may himself assume the responsibility referred to in paragraph 1.
If the holder of the authorization will not enforce the licensing conditions, the decision on cancellation of the authorization. .
Any other local person,who has obtained the agreement of the holder of the authorization and if the condition of the authorization is met.
(2) The holder of the authorization shall be obliged to notify the customs authorities of any change occurring after its issuing which might influence its contents and the conditions for its application.
If he personally fulfils the conditions laid down in Article 49, the holder of the authorization may himself assume the responsibility referred to in paragraph 1.
If the holder of the authorization, which were set deadlines to bring it into line permitting requirements are not fulfilled this requirement, it imposed a second penalty in the amount of three times.
To enable the customs authorities to satisfy themselves as to the proper conduct of operations, the holder of the authorization referred to in Article 263 shall.
Shall send to the holder of the authorization to use notification of approval of the study or makes a reasoned refusal.
In order to obtain the recognition according to the procedure laid down in this Chapter in one ormore of the Member States of a marketing authorization issued by a Member State, the holder of the authorization shall submit an application to the competent authority of the Member State or Member States concerned, together with the information and particulars referred to in Articles 12, 13(1), 14 and 25.
In addition the holder of the authorization shall request the reference Member State to prepare an assessment report in respect of the medicinal product concerned, or, if necessary, to update any existing assessment report.
(b) in certain special circumstances, where the nature of the goods in question andthe rapid turnover so warrant, exempt the holder of the authorization from the requirement to notify the competent customs office of each arrival of goods, provided that he supplies the said office with all the information it considers necessary to enable it to exercise its right to examine the goods should the need arise.
In addition the holder of the authorization shall request the reference Member State to prepare an assessment report in respect of the medicinal product concerned, or, if necessary, to update any existing assessment report.
(b) in certain special circumstances, where the nature of the goods in question and the rapid turnover so warrant,exempt the holder of the authorization from the requirement to notify the competent customs office of each arrival of goods, provided that he supplies the said office with all the information it considers necessary to enable it to exercise its right to examine the goods should the need arise.
In addition, the holder of the authorization shall request the reference Member State which granted the initial authorization to prepare an assessment report in respect of the veterinary medicinal product concerned, or, if necessary, to update it.
(1) the drug agency receives information submitted by the holder of the authorization to use information on serious suspected adverse reactions, occurring in the territory of the European Union or in a third country, by means of the database"EudraVigilance".
The holder of the authorization may ask for the import duty to be repaid or remitted where he can establish to the satisfaction of the customs authorities that compensating products obtained from import goods released for free circulation under the drawback system have been either.
In addition the holder of the authorization shall request the reference Member State to prepare an assessment report in respect of the medicinal product concerned, or, if necessary, to update any existing assessment report.
(1) The holder of the authorization shall be entitled to request the import duty to be reimbursed or remitted when he provides proof to the customs authorities that the imported goods under the drawback SYSTEM or the compensating products obtained from them are.
( b) the name and address of the holder of the authorization and the authorization number of the plant protection product and, if different, the name and address of the person responsible for the final packaging and labelling or for the final labelling of the plant protection product on the market;
The holder of the manufacturing authorization shall ensure that the excipients are suitable for use in medicinal products by ascertaining the appropriate good manufacturing practice.
The holder of the manufacturing authorization may enter into a contract with a third party to carry out the audit in his name and for his account.