A Competent Authority Arrangement is a bilateral agreement between the United States and the treaty partner to clarify or interpret treaty provisions. The Bulgarian Drug Agency is administration to the Minister of Health, whose competences, functions and activities are set out in three laws: According to the Law on Medicinal Products in Humane Medicine (LMPHM) BDA is a specialized body to the Minister of Health to supervise the quality, effectiveness and safety of medicines. 1000 Sofia tel: 003592 9301276 e-mail: ssimeonova@mh.government.bg Competent authority: Tel: +359 2 9301 214 Fax: email: web: www.mh.government.bg Areas of competence: Maslarska Anna Tel: +359 2 9301 214 Fax: - email: amaslarska@mh.government.bg Contact person: Dimitrova Neliya Tel: +359 2 9301 214 … The European Medicines Agency works closely with the national competent authorities of the Member States of the European Union (EU) and the European Economic Area (EEA) responsible for human medicines. The competent authority shall have a maximum of 60 working days as from the date of the written acknowledgement of receipt of the notification and all documents required to be attached to the notification on the basis of the list referred to in Article 32(4) (hereinafter referred to as ‘the assessment period’), to carry out the assessment provided for in Article 32(1) (hereinafter referred to as ‘the … 73 0 obj <>stream The national competent authorities are primarily responsible for the authorisation of medicines available in the EU that do not pass though the centralised procedure. perpetrator is a Bulgarian citizen, the competent authority is the prosecutor`s office at his/her place of residence. IMDG Code defines competent authority as any body or authority designated or otherwise recognized as such for any purpose in connection with IMDG Code. BULGARIA -the Chamber of Architects of Bulgaria, Tzar Assen Str. Competent Authority Arrangements also exist between the United States Internal Revenue Service and each United States Territory and Commonwealth tax agency … • A judge – during the trial stage �o ,�K�� "X���$ƹ�:0ߧpuEn�.6�h����Px�ɬ,��% �Z�fU5��"M�*ױ6K����D�j�Ke����'�m��r��#�j�Y�۝F)%7�q�8d��m �N��r�aG��m4�ȕ��T�f��4�5����P���|�*��y����. The functions of supervision and control of the compliance with the GDPR in Bulgaria are shared between the Commission for Personal Data Protection and the Inspectorate to the Supreme Judicial Council, the latter having competence only with regards to data processing by courts, prosecution offices and criminal investigative bodies in their capacity as judicial authorities. For approvals and special permits under 49 CFR please visit PHMSA site Exemption When IMDG Code… BG - 1000 Sofia Tel: +359 2 9301 214 Fax: email: ssimeonova@mh.government.bg web: www.mh.government.bg Areas of competence: Competent authority: National Center of Public Health and Analyses Address: 15, Ivan Ev.Geshov blvd Role of competent authority comes in various scenarios two of which are Exemptions and Approvals. Look through examples of competent authority translation in sentences, listen to pronunciation and learn grammar. Box 21826, 1513, Nicosia, CYPRUS Tel: (00357) 2287 7644 email: cyprus@etek.org www.etek.org.cy CROATIA Below are listed the competent authorities' websites pages dedicated to Supervisory Disclosure.CountryCompetent authorityAustriaFinancial Market AuthorityBelgiumNational Bank of BelgiumBulgariaBulgarian National BankCroatiaCroatian National Bank for credit institutions and Croatian Financial Services Supervisory Agency for investment firmsCyprusCentral Bank of CyprusCzech Competent authority process refers to all steps in the process of initiating and resolving a competent authority case. Following these steps will make your assignment easier and hopefully, more enjoyable. Sofia 1303 Bulgaria Tel. 1 / designated authority. The competent authorities in Bulgaria and Romania notified their own public right at the start of the EIA process, using the methods listed in the table. SOFIA 1040 Bulgaria … endstream endobj startxref Bulgaria: Ministry of Environment and Water: Yes: Yes: No: Yes: Bulgaria: Ministry of Health: … List of national macroprudential authorities and national designated authorities in EU Member States 1 List of national macroprudential authorities and national designated authorities in EU Member States Table 1 EU Member States with a single institution Country . In May 2019, EMA’s safety committee (PRAC) started a review of the non-steroidal anti-inflammatory medicines ibuprofen and ketoprofen following a survey by the French National Agency for Medicines and Health Products Safety (ANSM) which suggested that infection due to chickenpox (varicella) and some bacterial infections could be made worse by these medicines. In the same case, but if the perpetrator is not a Bulgarian citizen, the competent authority is a Prosecutor`s Office in Sofia. National competent authorities (veterinary), List of national competent authorities in the EEA, Information on coronavirus disease (COVID-19), Austrian Agency for Health and Food Safety, Federal Agency for Medicines and Health Products, Agency for medicinal products and medical devices of Croatia, Ministry of Health - Pharmaceutical Services, National Agency for the Safety of Medicine and Health Products, Federal Institute for Drugs and Medical Devices, National Institute of Pharmacy and Nutrition, Health Products Regulatory Authority (HPRA), Office of Health / Department of Pharmaceuticals, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, National Authority of Medicines and Health Products, National Authority of Medicines and Medical Devices, Agency for Medicinal Products and Medical Devices of the Republic of Slovenia, Spanish Agency for Medicines and Health Products, Information on COVID-19 from HMA and EEA Member States, Parque de Saúde de Lisboa - Avenida do Brasil, 53. 59 0 obj <> endobj Competent Authority Arrangements also exist between the United States Internal Revenue Service and each United States Territory and Commonwealth tax agency to address issues of interest to the respective jurisdictions (at the end of this page). : 0030 210 3375325 or 0030 210 3375326 or 0030 210 3375192 or 0030 210 3375301 perpetrator is a Bulgarian citizen, the competent authority is the prosecutor`s office at his/her place of residence. 64 0 obj <>/Filter/FlateDecode/ID[]/Index[59 15]/Info 58 0 R/Length 49/Prev 33755/Root 60 0 R/Size 74/Type/XRef/W[1 2 1]>>stream Country Name of authority Address e-mail, website, phone number Bulgaria Министерство на икономиката (Ministry of Economy) 8 Slavianska Str, 1000 Sofia Bulgaria Croatia Ministarstvo vanjskih i europskih poslova; Služba za izvoznu kontrolu (Ministry of … For all legal actions brought, judgments given and acts issued until 28 January 2019, matrimonial matters fall under the jurisdiction of Bulgarian courts if one of the spouses is a Bulgarian citizen or is habitually residing in Bulgaria. CONTACT INFORMATION OF THE COMPETENT AUTHORITY IN THE SEAFARERS’ COUNTRY OF RESIDENCE BULGARIA a) Authority/Contact person: Bulgarian Maritime Administration b) Telephone number: +35 929 300910 c) Email address: bma@marad.bg CZECH REP. a) Authority/Contact person: Ministry of Labour and Social Affairs b) Telephone number: +420 221 922 378 c) Email address: … Bulgaria: Bulgarian Drug Agency: 8 Damyan Gruev Str. Tel: +43 (1) 71162 655902 Fax: +43 (1) 71162 655999. Nationale Bank van België/Banque Nationale de Belgique . E-mail:w2@bmk.gv.at Competent authority for the issuing of certificates of approval They also supply thousands of European experts who serve as members of the Agency's scientific committees, working parties or in assessment teams supporting their members. endstream endobj 60 0 obj <> endobj 61 0 obj <> endobj 62 0 obj <>stream +43 5 0555-0 Fax: +43 5 0555-22019 www.ages.at: Belgium: Federal Agency for Medicines and Health Products: Eurostation building, block 2 place Victor Horta, 40/ 40 1060 Brussels Belgium Tel. competent authority in Bulgarian translation and definition "competent authority", English-Bulgarian Dictionary online %%EOF the Minister of Justice National Organ for the Hague Conference Ministry of Justice of the Republic of Bulgaria "International Legal Co-operaton and European Affairs" Directorate 1, Slavyanska Str. d) The term “Bulgaria” means the Republic of Bulgaria. Expatriate Handbook for Bulgaria 2015 Introduction International assignees working in Bulgaria This booklet traces your assignment to Bulgaria through several steps - what to do before you arrive in the country, what to do once you are here, and what to do before you leave. Main competent authority: Federal Ministry for Climate Action, Environment, Energy, Mobility, Innovation and Technology Supreme Navigation Authority Radetzkystrasse 2 A-1030 Vienna. Country Name Contact details; Austria: Austrian Agency for Health and Food Safety: Spargelfeldstraße 191 220 Wien Austria Tel. Bulgaria Competent authority: Ministry of Health State Health Control Directorate Address: 5, Sveta Nedelya Sq. The following competent authorities comply or intend to comply with ESMA’s Guidelines on performance fees in UCITS and certain types of AIFs (ESMA34-39-992) Competent authority Complies or intends to comply Comments Member States AT Austria Financial Market Authority (FMA) Yes https://www.fma.gv.a t/en/eu/esma-guidelines/ BE Belgium Financial Services and Markets Authority … +359 2 890 … For more information on how EMA works together with the national competent authorities, see European medicines regulatory network. Instructions by the Bulgarian Drug Agency to the submitters for preparation of a list of medical devices attending an application form for registration, notification or submission of information in accordance with Chapter two of the Law on Medical Devices . 2 Contents 1. Macroprudential authority. : 0030 210 3375710 or 0030 210 3375711. Tel. h�b```f``a Vn�f`B��'NY�����F��`���Х���W���0�@���ޝl8�hb�a`�k��Qf`h������&܇� ��x Summary of the Facts .....4 2. 0 1, Sofia 1000, BULGARIA Tel: (00359) 2 980 9315 Fax: (00359) 2 980 9324 kab_imi@abv.bg www.kab.bg CYPRUS -Cyprus Scientific and Technical Chamber, Kerverou kai Thiseos, P.O. %PDF-1.5 %���� Czech R The national competent authorities publish information on coronavirus disease (COVID-19) and on COVID-19 treatments and vaccines in national languages. Bulgaria Member since: 22-IV-1999: National Organ: H.E. The Bulgarian authorities and EIA experts consulted the public during the preparation of the preliminary EIA and on the preliminary and final EIA report. The IRS shall publish a list identifying all Partner Jurisdictions. e) The term “Partner Jurisdiction” means a jurisdiction that has in effect an agreement with the United States to facilitate the implementation of FATCA. Directorate General for Taxation of the Hellenic Ministry of Finance. 1000 Sofia tel: 003592 9301276 e-mail: ssimeonova@mh.government.bg Competent authority: Tel: Fax: email: web: www.mh.government.bg Areas of competence: Maslarska Anna Tel: +359 2 9301 214 Fax: - email: amaslarska@mh.government.bg Contact person: Tzolova Svetla Tel: + 359 2 8506 260 Fax: - email: … hޤT[o�0�+�q{�|l��HI�t��. Bulgaria Ministry of Health State Health Control Directorate Address: 5, Sveta Nedelya Sq. k) the term "competent authority" means: i) in Bulgaria: the Minister of Finance or an authorized representative; and ii) in the United States: the Secretary of the Treasury or his delegate; List of national competent authorities in the EEA. Bulgaria. Belgium . Specialised tax directorates (VAT, income tax, capital tax) Tel. Check 'competent authority' translations into Bulgarian. f) The term “Competent Authority” means: Many translated example sentences containing "competent authorities" – Bulgarian-English dictionary and search engine for Bulgarian translations. h�bbd``b`��@�� H0 �B�N�$ �[ �� Bulgaria (the “Competent Authorities”) “shall enter into an agreement or arrangement under the mutual agreement procedure provided for in Article 24 of the Convention”, in order to establish and prescribe the rules and procedures necessary to implement on the draft list of the competent supervisory authority of Bulgaria regarding the processing operations subject to the requirement of a data protection impact assessment (Ar ticle 35.4 GDPR) Adopted on 25th September 2018. For the United Kingdom, as of 1 January 2021, European Union law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland / NI. BFSA remains the competent authority on official control on all food imports, exports, and manufacturing with the exception of bottled water (mineral, spring, and table water) (Art.28/ Food Law) Law on the Establishment of Bulgarian Food Safety Agency – published in Official A Competent Authority Arrangement is a bilateral agreement between the United States and the treaty partner to clarify or interpret treaty provisions. *h���K��K������@�ښ6:����� ! Medical Devices categories. The product information of many … 2. Email for the Greek competent authority: ypoik@otenet.gr. 9 Which is the competent authority to turn to in cases of disputes and other legal issues? Ministry of Health Public Health Directorate Address: 5, Sveta Nedelya Sq. For a full list of these information resources, see: European Medicines AgencyDomenico Scarlattilaan 61083 HS AmsterdamThe Netherlands. 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