Примери за използване на Relevant national competent на Английски и техните преводи на Български
{-}
-
Medicine
-
Colloquial
-
Official
-
Ecclesiastic
-
Ecclesiastic
-
Computer
Ensuring access to all relevant national competent authorities.
The wording below should be adapted at an individual product level and therefore, the type of variation to be submitted should be agreed with the relevant National Competent Authority(NCA) prior to the submission.
Financial market participants shall report it to the relevant national competent authority which shall communicate it to the relevant ESA without delay.
New clinical andbioanalytical studies are performed and submitted to the relevant national competent authorities.
Inform the relevant national competent authorities of its intention to physically locate the repository or part of it in their territory and notify them once the repository becomes operational;
The clinical study report should be submitted to the relevant National Competent Authorities.
The abovementioned study results should be provided to the relevant national competent authorities for assessment prior to placing CattleMarker IBR Inactivated on the EU market and within 24 months of the Commission Decision.
The Committee recommends that these marketing authorisations(annex IB)should be suspended unless the medicinal product is considered critical by the relevant national competent authorities.
(16) In many cases,criminal activities underlie incidents that should be notified to the relevant national competent authorities under Directive(EU) 2016/1148 of the European Parliament and the Council46.
Furthermore, the Committee recommends that the concerned marketing authorisations should be suspended unless the medicinal product is considered critical by the relevant national competent authorities.
Whenever the relevant national competent authority or the relevant ESA disagree with the information reported as referred to in paragraphs 2 and 2a, financial market participants shall review and correct the information disclosed.
The data resulting from this study should be provided to the relevant national competent authorities for assessment.
Member States shall ensure that the relevant national competent authorities set up a publicly accessible register of unlawful acts that have been subject to injunction orders in accordance with the provisions of this Directive.
(c)‘crowdfunding service provider' means a legal person who provides one or more crowdfunding services andhas been authorised for that purpose by the relevant national competent authority in accordance with Article 10 of this Regulation;
Where on the basis of these criteria the relevant national competent authorities of the EU Member States consider that a medicinal product is critical, the suspension of the concerned marketing authorisation(s) may be deferred by the period for which the medicinal product is considered critical.
Text proposed by the Commission Amendment(16) In many cases,criminal activities underlie incidents that should be notified to the relevant national competent authorities under Directive(EU) 2016/1148 of the European Parliament and the Council46.
In setting up the repositories system, the legal entity or entities referred to in paragraph 1 shall consult at least wholesalers, persons authorised orentitled to supply medicinal products to the public and relevant national competent authorities.
If serious adverse events or reactions occur in relation to a combined advanced therapy medicinal product,the Agency shall inform the relevant national competent authorities responsible for implementing Directives 90/385/EEC, 93/42/EEC and 2004/23/EC.
In order to remove any traces of cow's milk proteins from their finished product, the MAHs should replace the current formulations in their marketing authorisations with formulations free from cow's milk proteins andsubmit for assessment the corresponding documentation to the relevant National Competent Authorities.
The statement of noncompliance with GMP of PII clarifies that marketing authorisation holders are requested to contact the relevant National Competent Authority(NCA) to verify whether their products are considered medically critical to public health in their territory.
The MAH/applicant has successfully demonstrated that the virus removal/inactivation steps are appropriately controlled and will provide the final reports of the virus and TSE removal studies andthe updated risk assessment analysis by 31 May 2019 to the relevant national competent authorities.
The Company has already planned to assess long-term antibody persistence and, to complete this procedure,should formally commit to providing to the relevant national competent authorities for assessment the data from longer-term follow-up of studies 010/022 and 013 with anticipated timelines.
The CMDh is of the position that each MAH shall be responsible for the implementation and the supervision of the access controlled program as follows:- The MAH should develop the training materials for relevant HCPs expected to prescribe/ administer HES solutions for infusion and agree the exact content andformat of these materials with the relevant national competent authorities.
Where on the basis of these criteria the relevant national competent authorities of the Member States consider that a medicinal product is critical, the suspension of the concerned marketing authorisation(s) may be deferred by the period for which the medicinal product is considered critical(period which can not exceed twenty-four months from the Commission Decision).
The presence of independent permanent members and CCP-specific members should ensure that decisions made in the CCP Executive Session are consistent, appropriate andproportionate across the Union and that the relevant national competent authorities, central banks of issue and observers are involved in the decision-making on issues concerning a CCP established in a Member State.
The Applicant/ MAH is requested to commit to submitting for assessment, to the relevant national competent authorities, the results from the long-term antibody persistence data from the ongoing studies with Menitorix i. e. subjects from booster studies 013 and 022 are being followed up for antibody persistence as follows: o Over 4 years of follow up of subjects from study 013 in studies 027, 028 and 029. o Five years follow-up from 010/ 022 in subsequent studies 023, 024, 025 and 026.
To conduct a non-interventional post-authorisation registry of patients treated with pomalidomide for relapsed and refractory multiple myeloma to monitor the incidence of adverse drug reactions in the“real world situation” and to monitor the implementation and compliance of the Celgene PPP andcontrolled distribution system on a country basis in agreement with the relevant National Competent Authority(ie., monitoring of Patient Card completion).
(261) In order to ensure that disabled end-users with disabilities benefit from competition andthe choice of service providers enjoyed by the majority of end-users, relevant national competent authorities should specify, where appropriate and in light of national conditions, and after consulting persons with disabilities, consumer protection requirements for disabled end-users with disabilities to be met by undertakings providing providers of publicly available.
The MAH should submit the relevant data to national competent authorities for review, in line with the agreed milestones for evaluation and reporting as described in the RMP.
The label is awarded by the relevant national organisation(Competent Body) that checks your application.