Примери за използване на Authorities in each member state на Английски и техните преводи на Български
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National authorities in each Member State should ensure the exchange of this information.
Details of the operation of the registry shall be agreed with the National Competent Authorities in each Member State.
National authorities in each Member State(the SIRENE Bureaux), should ensure the exchange of this information.
Products classified higher than class I are evaluated by notified bodies under the supervision of national competent authorities in each Member State.
National authorities in each Member State(the SIRENE Bureaux), should ensure the exchange of this information in a fast and efficient manner.
Details of the PPP should be agreed wth the National Competent Authorities in each Member State and put in place prior to the launch of the medicinal product.
The National Competent Authorities in each Member State shall discuss and agree with the Marketing Authorisation Holder(MAH) measures to enhance further the monitoring of patients treated with Tysabri(e.g. registries, post-marketing surveillance studies) as appropriate and must ensure that the MAH implements the agreed measures within an agreed time frame.
The MAH shall ensure that, following discussion andagreement with the National Competent Authorities in each Member State where Aubagio is marketed, at launch and after launch, all healthcare professionals who are expected to use Aubagio are provided with the following items.
EThe competent authorities in each Member State shall designate a single national regulatory body for the road passenger transport sector.
The Marketing Authorisation Holder must, following discussions andagreement with the National Competent Authorities in each Member State where TYSABRI is marketed, ensure that all physicians who intend to prescribe TYSABRI are provided with a physician pack containing the following elements.
The establishment of fully independent supervisory authorities in each Member State is essential to ensure the protection of natural persons with regard to the processing of their personal data in the EU 44.
Without prejudice to paragraph 1, the tax authorities in each Member State shall provide the competent NSAs with information for statistical purposes related to exports and imports of goods as specified in Annex V.
Eurocode standards recognise the responsibility of regulatory authorities in each Member State and have safeguarded their right to determine values related to regulatory safety matters at national level where these continue to vary from State to State. .
The MAH ensures that, following discussions andagreement with the National Competent Authorities in each Member State where Eylea is marketed, ophthalmological clinics where Eylea is expected to be used are provided with an updated physician information pack containing the following elements.
The MAH shall ensure that, following discussions andagreement with the National Competent Authorities in each Member State where Exelon patch is marketed, all physicians who are expected to prescribe Exelon patch are provided with an information pack containing the following elements.
The MAH shall ensure that, following discussion andagreement with the National Competent Authorities in each Member State where Nuedexta is marketed, at launch and after launch, all healthcare professionals who are expected to prescribe Nuedexta are provided with the following items.
The MAH shall ensure that, following discussion andagreement with the National Competent Authorities in each Member State where ADASUVE is marketed, at launch and after launch, all healthcare professionals who are expected to use ADASUVE are provided with an information pack containing the following items.
Through the National Annex the Eurocode programme has recognised the responsibility of regulatory authorities in each Member State and has safeguarded their right to determine values related to regulatory safety matters at a national level where these continue to vary from State to State. .
The MAH shall ensure that, following discussions andagreements with the National Competent Authorities in each Member State where Lucentis is marketed, at launch and after launch all ophthalmological clinics where Lucentis is expected to be used are provided with an up-to-date patient information pack.
The MAH shall ensure that, following discussions andagreement with the National Competent Authorities in each Member State where OZURDEX is marketed, at launch and after launch all ophthalmological clinics where OZURDEX is expected to be used are provided with an up-to-date patient information pack.
The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where Zalviso is launched all healthcare professionals who are expected to prescribe Zalviso are informed through an information letter on having access to/ are provided with the following items.
The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where Intuniv is launched all healthcare professionals who are expected to prescribe Intuniv are informed through an information letter on having access to/ are provided with the following items.
The MAH shall ensure that, following discussions andagreement with the National Competent Authorities in each Member State where NeuroBloc is marketed, at launch and after launch all physicians who are expected to use NeuroBloc are provided with updated physician information pack containing the following elements.
The MAH shall ensure that, following discussions andagreement with the National Competent Authorities in each Member State where IONSYS is launched all healthcare professionals who are expected to prescribe, dispense or administer IONSYS are informed through an information letter on having access to/ are provided with the following items.
The MAH shall ensure that, following discussions andagreement with the National Competent Authorities in each Member State where Macugen is marketed, at launch and after launch all ophthalmological clinics where Macugen is expected to be used are provided with an updated physician information pack containing the following elements.
The MAH shall ensure that, following discussions andagreement with the National Competent Authorities in each Member State where Amyvid is marketed, at launch and after launch, all physicians who are expected to use Amyvid have access to a training course in order to ensure accurate and reliable interpretation of the PET images.
The MAH shall ensure that, following discussions andagreement with the National Competent Authorities in each Member State where Rivastigmine 3M Health Care Ltd. is marketed, at launch and after launch of the transdermal patch all physicians who are expected to prescribe Rivastigmine 3M Health Care Ltd. are provided with an information pack containing the following elements.
The MAH shall ensure that,following agreement with the National Competent Authorities in each Member State where LEMTRADA is marketed, at launch and after launch, all physicians who intend to prescribe LEMTRADA are provided with an updated physician educational pack containing the following elements: The Summary of Product Characteristics HCP guide Prescriber checklist Patient guide Patient alert card The HCP guide shall contain the following key messages.