The proposed texts were submitted by the Pharmacopoeial Discussion Group. Clause 6 - Optional Docking clause (a) An entity that is not a Party to the Clauses may, with the agreement of the Parties, accede to these Clauses at any time, either as a data exporter or as a data importer by completing Annex I.A [List of Parties], Annex I.B [Description of the transfer(s)], and 1, 2 One of its most significant changes is found in Annex VI, which covers the labeling requirements for authorized and unauthorized investigational medicinal products (IMPs) and auxiliary medicinal products used in EU clinical trials. Scientific recommendation on the revision of Annex II to Regulat ion (EU) 2019/6 on veterinary medicinal products EMA/CVMP/287826/2019 Page 5/89 . BG - Преводът е предоставен от Центъра за преводи за органите на Европейския съюз. to this Notice. annex i: classification and labelling requirements for hazardous substances and mixtures This annex sets out the criteria for classification in hazard classes and in their differentiations and sets out additional provisions on how the criteria may be met. These sanctions or restrictive measures will be lifted in accordance with Annex V. 3. 2. Data requirements for an application for the amendment of Annex I to the BPR (first inclusion of an active substance or amendment of restrictions) Regulation (EU) No 88/2014 specifies the data requirements for categories 1 to 5 and 6. EU/CO/PE/Annex II/en 6 SECTION 1 GENERAL PROVISIONS ARTICLE 1 Definitions For the purposes of this Annex: − "aquaculture" means the farming of aquatic organisms, including fish, molluscs, crustaceans, other aquatic invertebrates and aquatic plants, from seedstock such as eggs, fry, fingerlings 2 . The EU represents that the provisions listed in Section 1 above constitute the full and complete list of all EU nuclear-related sanctions or restrictive measures. 7 . Annex 3-C Information referred to in article 3.5; Annex 3-D Text of the statement on origin; Annex 3-E On the Principality of Andorra; Annex 3-F On the Republic of San Marino; Annex 6 Food additives. They shall also explain The ECHA website is temporarily down for maintenance. Annex 0 is filled in at national level (meaning same justifications are applicable to all RBDs), it should be reported in the Folder National RBDSUCA (see below). Appendix 6 (FAA Annex to EASA Form 6) – Section A, Appendix 6. 3. Further guidance from the Agency on specific topics to compliment some elements of the advice will be required. Appendix EU: EU, other EEA and Swiss citizens and family members Purpose . (8) The rabies antibody titration test referred to in point II.3.1: - must be carried out on a sample collected by a veterinarian authorised by the competent authority, at least 30 days after); EN 2019/1293. L 174/88 Official Journal of the European Union 1.7.2011EN (1) OJ C 306, 16.12.2009, p. 36. Information about the European Union is available on the Internet. PRODUCT VERIFICATION AND VALIDATION The documentation shall contain the results and critical analyses of all verifications and validation tests and/or studies undertaken to demonstrate conformity of the device with the requirements of this Regulation and in particular the applicable general safety and performance requirements. 70% of the EU citizens experience too high noise levels in cities. (4) Insertion of a new definition (48a) (definition of the term flight crew), to ensure alignment with ICAO Annex 6. Sterilization is not an absolute process. Also, scroll to the bottom for some of our Annex 1 compliant viable non viable instruments and data management solutions. EU GMP Annex 1 specifies the same Grade A for both (filling). In urgent cases, please submit your question through the contact form.You can also call the ECHA Switchboard: +358 9 6861 80. The modifications we propose to make are to reflect the changes in the legislative framework that will be implemented in the event that the United Kingdom (UK) leaves the European Union (EU) without a deal. Parts 2 and 3 of Annex I to Implementing Regulation (EU) No 577/2013. They often cannot afford a car and dependent on public transport in any case. Entities shall explain in the narrative accompanying the template any material difference between the own funds amounts disclosed and the IFRS 9 fully loaded amount at the resolution group level. 6 Annex B: Access to the GSA's premises 1. Gener 2014 Anne 6 I ANNEX 6 Key performance indicators Attaining good performance is one of the EMCDDA’s strategic goals for 2013–15. 2. Caution shall be taken when using those non-harmonized classifications. 5. 536/20141–2 is expected to be implemented by October 2018. Annex 8-A Regulatory cooperation on financial regulation; Annex 8-B Schedules for chapter 8 Annex 8-B I Reservations for existing measures This may imply revision of existing guidelines or developing new ones, as a ppropriate. {9} [ ] 7. DE - … 2. 2. If you search ethanol (CAS 64-17-5), the following screenshot will pop up with harmonized classification for ethanol: Please note that C&L Inventory also contains other non-harmonised classification and labelling information submitted by companies themselves. 2 Contents ... ( to the Agency by an official letter or request form signed by the legal representative of the beneficiary, that (48a) Flight crew[ means a licensed flight crew member charged with duties essential to the operation of an aircraft during a flight duty period. Compulsory GHS classifications in the annex VI are available for search from ECHA's classification &labelling inventory (C&L Inventory). Added a note in Section B, Appendix 1, Para. Audit criteria The audit criteria are derived from Article 30 of the Interoperability Directive and from the Agency Technical set out in Annex 6.1.a and 6.1.b. Annex IV: Energy 5: Annex V: Free Movement of Workers 6: Annex VI: Social Security 7: … Commission Implementing Regulation (EU) 2017/373 of 1 March 2017 laying down common requirements for providers of air traffic management/air navigation services and other air traffic management network functions and their oversight, repealing Regulation (EC) No 482/2008, Implementing Regulations (EU) No 1034/2011, (EU) No 1035/2011 and (EU) 2016/1377 and amending Regulation (EU… This annex is the result of the Q4B process for the Uniformity of Dosage Units General Chapter. We also have FAQs with answers below. Introduced on 16 April 2014, the European Union clinical trial regulation No. General remarks The recordings and the slides of our recent webinar: “Ventilative Cooling – Design and examples” held on March 26 th, 2020 and organised with the support of IEA-EBC annex 62 on ventilative cooling and the venticool platform, and in cooperation with the Air Infiltration and Ventilation Centre, are now available online.. On 20 December 2019, the Technical Expert Group on Sustainable Finance (TEG) published a Handbook on Climate Benchmarks and benchmarks’ ESG disclosures The Handbook follows on the publication of the TEG final report on Climate benchmarks that was published on 30 September 2019. Effects of the lifting of EU economic and financial sanctions 3.1. It can be accessed through the Europa server ( Luxembourg: Publications Office of the European Union, 2011 ISBN 978-92-9213-209-5 ISSN 1725-2237 doi:10.2800/76903 In order to measure the achievement of this goal, the agency has committed to improving its performance measurement system by developing, among other things, KPIs for each main area of work. The railway link to the elements listed in Annex II of Regulation (EU) No 1315/2013 and to the infrastructure components as referred to in Article 11 of Regulation (EU) No 1315/2013 that are located on the core network corridor shall be equipped and put into operation at the date specified for the respective core network corridor section. 6. {6} [ ] 4. It aims to facilitate the recognition of pharmacopoeial procedure for the uniformity of dosage units by regulatory authorities in … Annex 8. Clarified Work Away and D100 Procedures-Section B, Part V, Para 1.1. EUROPEAN UNION AGENCY FOR RAILWAYS Annex Provisions on auditing notified conformity assessment bodies 120 Rue Marc Lefrancq | BP 20392 | FR-59307 Valenciennes Cedex 2 / 6 Tel. 3. {7} 32009 L 0035: Directive 2009/35/EC of the European Parliament and of the Council of 23 April 2009 on the colouring matters which may be added to medicinal products (OJ L 109, 30.4.2009, p. 10). They need affordable apartment prices and find them there. {8} [ ] 6. Annex 6 583 583 ACETAMIPRID (246) BEEF CATTLE MAX Commodity CC Residue (mg/kg) Basis DM (%) Residue dw (mg/kg) Diet content (%) Residue Contribution (ppm) US- CAN EU AU JP US-CAN EU AU JP Corn, sweet stover AF/AS 20 HR 83 24.10 40 9.639 Cotton gin byproducts AM/AV 18 HR 90 20.00 5 40 1 Annex 6 Guidelines and Templates for Reporting and Amendments . The effect of these proposed modifications is to ensure that the references in the Please try again later. It is relative to initial bioburden. EU1. EU KM2: Key metrics - MREL and, where applicable, G -SII Requirement for own funds and eligible liabilities 4. Contamination reduces effectiveness of sterilization and contaminants from the air can deposit on surfaces and reduce the effects of sterilization. Mostly households with lower income live in the city areas with a poorer environment. DA - Denne oversættelse er udarbejdet af Oversættelsescentret for Den Europæiske Unions Organer. Capital Adequacy Overview (CA) 1.1. Annex VI . As of June 2013, there are 192 parties to the Kyoto Protocol to the United Nations Framework Convention on Climate Change, which aims to combat global warming.This total includes 191 states (189 United Nations member states as well as the Cook Islands and Niue) and one supranational union (the European Union). For the purposes of this Annex, Regulation (EU) No 575/2013 is referred to as ‘CRR’, and Directive 2013/36/EU of the European Parliament and of the Council is referred to as ‘CRD’. Contractors or subcontractors and their personnel shall comply with the GSA's internal security and safety rules and Regulations and shall follow any instructions given by the GSA's Security Department. PART II: TEMPLATE RELATED INSTRUCTIONS 1. CS - Tento překlad vypracovalo Překladatelské středisko pro instituce Evropské unie. The objective of this paper is to evaluate the compliance of the EASA system and EU-OPS with ICAO Annex 6 standards and recommended practices concerning safety management systems (SMS) for air operators as required by ICAO per 1 January 2009. {10} 32010 L 0063: Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on Stay tuned for more spinets or get a summary of the EU GMP Annex 1 Draft Revisions by reading the paper below or watching the on-demand webinar at the right. If the Annex 0 is filled in at RBD 6.1. +33 (0)327 09 65 00 | 4. (2) OJ C 141, 29.5.2010, p. 55.