June 2017 Sebastiaan Scholte, outgoing Chairman of the Cool Chain Association, speaks to TIACA Times about the organizations plans for the year. Sebastiaan, you. Western Wood Products Association, representing Western lumber manufacturers. European Medicines Agency Marketing authorisation. Where can I find the relevant documents regarding the pharmaceutical legislationThe treaties on which the European Union and the European Communities are founded are available. To exercise the Unions competences, the institutions may adopt regulations, directives, decisions, recommendations and opinions. Information about the hierarchy of the European Union texts can be found in annex I to volume 2. A Procedures for marketing authorisation Chapter 1 Marketing authorisation. The rules governing medicinal products in the European Union concerning medicinal products for human use is published on the European Commission website Volume 1 Pharmaceutical legislation, contains most of the relevant Directives, Regulations, decisions and communications Volume 2 Notice to applicants. Volume 2. A Procedures for marketing authorisation. Introduction Chapter 1 Marketing authorisation Chapter 2 Mutual recognition Chapter 3 Community referral Chapter 5 Variations Chapter 6 Community marketing authorisation Volume 2. B Presentation and content of the dossier provides guidance for the compilation of dossiers for applications for marketing authorisation, and is applicable for the centralised procedure and national procedures, including mutual recognition and decentralised procedures Volume 2. C Regulatory guidelines related to procedural and regulatory requirements, e. Sm. PC, package information and classification for the supply, readability of the label and package leaflet requirements Volume 3 Scientific guideline Volume 4 Good manufacturing practices Volumes 5 to 8 apply only to veterinary medicinal products Volume 9 Pharmacovigilance With the application of the new pharmacovigilance legislation as from July 2. A is replaced by the good pharmacovigilance practice. Requirements For Licensing A New Biological Product Deviations' title='Requirements For Licensing A New Biological Product Deviations' />C. C. 2. 2 proposal for a new field of technical activity proposal for. Chapter 56 Accident Prevention INTRODUCTION. Jorma Saari. According to International Labour Office statistics, 120 million occupational accidents occur annually at. One year period of protection for new indications for well established substances. According to Article 105 of Directive 200183EC as amended, where an. Polpharma Biologics discovery and development of innovative biopharmaceuticals, biobetters and biosimilars. Career opportunities in biotechnology. The Occupational Outlook Handbook is the governments premier source of career guidance featuring hundreds of occupationssuch as carpenters, teachers, and. However, until the availability of the respective GVP modules, volume 9. A remains the reference. GVP modules refer to the Commission Implementing Regulation No 5. Images/Site_Setup/Regulatory_Focus/News/2017/06/CBER%20table.png' alt='Requirements For Licensing A New Biological Product Deviations' title='Requirements For Licensing A New Biological Product Deviations' />June 2. This is a legally binding act published by the European Commission in June 2. Volume 1. 0 Clinical trials. The European Commission website offers the possibility to create a CD ROM with the content of the rules governing medicinal products in the European Union, which can be used off line with an integrated search engine. Scientific guidelines related to quality, safety and efficacy are available, together with concept papers, draft guidelines and overviews of comments received during the consultation on draft versions. Install Cab File In Windows Cell there. The Agency also publishes procedural and technical guidance and document templates, which are intended to provide technical and procedural advice to applicants for marketing authorisations for medicinal products coming within the scope of the centralised procedure, in particular References. How can I tell if I am duly established in the EEA as an applicant The marketing authorisation holder MAH is the person who holds the authorisation to place a medicinal product on the market and is legally responsible for marketing the medicinal product. The granting of a marketing authorisation by a competent authority does not discharge the holder from civil and criminal liability as provided for by European Union law. The MAH may be a natural or legal person. The MAH of a centralised marketing authorisation must be established within the European Economic Area EEA Norway, Iceland, Liechtenstein and the Member States of the European Union. In order to fulfil this requirement, the MAH must have a permanent legal structure that is formed in accordance with the law of an EEA Member State and allows the concerned holder to assume the duties and responsibilities as well as to perform the tasks laid down by Union law. Companies or firms formed in accordance with the law of a Member State and having their registered office, central administration or principal place of business within the EEA will be treated in the same way as natural persons who are nationals of Member States. An applicant should demonstrate that it is duly established in the EEA. A proof of establishment from the applicant company is required by the Agency in order for an application to be validated e. United Kingdom, a certificate of incorporation issued by the Registrar of Companies, and in France, an extrait du registre du commerce et des socits. This proof of establishment should be included in annex 5. It should be emphasised that while the MAH may delegate certain activities to third parties, the MAH remains responsible for assuring all the obligations imposed on MAHs by the European legislation and by national law, as applicable. References. 1. 3 What special support is available for micro, small and medium sized enterprises SMEs Rev. February 2. 01. Incentives and assistance are available from EMA for SMEs, which focus on reducing financial and administrative entry hurdles for SMEs in pre marketing authorisation procedures such as scientific advice, the application for marketing authorisation and inspections. These include Administrative and procedural assistance from the SME Office at the Agency. Fee reductions for scientific advice, scientific services and inspections 9. Fee exemptions for certain administrative services excluding parallel distribution. Deferral of the fee payable for an application for marketing authorisation or related inspection. Conditional fee exemption where scientific advice is followed and a marketing authorisation application is not successful. Certification of qualitynon clinical data for advanced therapy medicinal products ATMPs intended for human use. Assistance with translations of the product information documents submitted in a centralised application for marketing authorisation. Waiver of the Med. DRA licensing fee when registering with Eudra. Vigilance. 1. In determining which companies are eligible for SME incentives, EMA applies the EU definition of micro, small and medium sized enterprises provided in Commission Recommendation 2. EC. Companies are classified according to their size micro, small or medium Micro enterprises employ less than 1. Small enterprises have fewer than 5. Medium enterprises have less than 2. Depending on the category in which the enterprise fits, some or all of the headcount and financial data from other partner or linked enterprises may need to be counted when calculating whether the SME criteria are met. Further information on the definition of an SME is available in The new SME definition User guide and model declaration, published by the European Commission. A declaration of SME status form available on EMA website on SMEs should be submitted to the SME Office prior to requesting financial or administrative assistance from the agency. SME Office. The SME office has been set up within the agency to address the particular needs of smaller companies. The office aims to facilitate communication with SMEs through dedicated personnel within the agency who will respond to practical or procedural enquiries, monitor applications, and organise workshops and training sessions for SMEs. Fee ReductionsDeferrals. SME applicants wishing to request a fee reduction andor deferral should address a letter of intent to the SME Office see below of the EMA.