Community authorisations

The procedures for obtaining a Community marketing authorisation are defined in EC Regulation No. 726/2004. The types of human-use medicinal products for which the procedure may be used are shown in Eigure 6.14. The applicant should notify the EMEA of their intention to submit an application at least 7 months 

APPLICATION TO MARKET A NEW DRUG, BIOLOGIC, OR AN ANTIBIOTIC DRUG FOR HUMAN USE 

APPLICANT AOOAESS N imbef, Street, CHy, State, Country. ZIP Code or Man Code, and u.S. Licente number if prevtouely ittued)  

AUTHORISED u S.AGEhfT NAME L ADDRESS (filumtier, Street. City.i ZiP Code, ieteptior e i FAX number) IF APPLICABLE 

NEW DRUOOR AMTIHIOTtCAPPUCATtON NUMBER, OR BIOLOGICS LICENSE APPLICATION NUMS6R (XpreviOiiSiytSSueO) 

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Outside of the products that come within the scope of Community Authorisations, all other products can only be licensed via application to the Competent Authorities of individual Member States. However, through the use of either decentralised or mutual recognition procedures it is possible to obtain authorisations on the basis of a dossier assessment conducted by a single Member State. 

The procedures and timelines for obtaining marketing authorisations for veterinary products are essentially the same as those for human medicines. Extensive guidance can be found in The Rules Governing Medicinal Products in the European Union, Volume 6 - Notice to Applicants, Veterinary Medicinal Products. The products that may follow centralised procedures and receive Community authorisations are shown in Eigure 7.5. All other products must obtain authorisations from national... 

Conceptually, this procedure for Community authorisations (also known as the centralised procedure) resembles a hybrid of the national procedure and the mutual recognition procedure, with the differences that first, the application is submitted to EMEA second, the dossier supporting the application undergoes a detailed assessment by the CHMP before approval in any Member State of the EU third, the applicant is provided with an opportunity to clarify any issues raised by any of the EU Member States fourth, the procedure naturally has an extended time frame but stUl with predetermined deadlines and finally, the applicant ends up with an approval or a refusal to market the product in all or any Member States of the EU. The centralised procedure is shown in Figure 17.2. 

The new Reg. 726/2004 now makes the authorisation procedure compulsory for orphan medicinal products and medical products for human use containing an entirely new active substance for the treatment of AIDS, cancer, neurodegenerative disorder or diabetes. See Annex to Regulation listing all products now requiring Community authorisation and those needing it as of 2008. 

Summary of Product Characteristics (SmPC) (for products with marketing authorisation in the Community)... 

Requests for permission to conduct clinical trials with pharmaceuticals in the US are termed Investigational New Drug Applications (INDs). The applications are actually a request for an exemption to supply a drug without a marketing authorisation. A cover sheet (Form 1571) must accompany the application. This cover sheet should also be used with each subsequent communication with the FDA, with each form consecutively numbered, starting at 000 for the initial submission. A copy of the form is shovm in Figure 5.6. 

EC) No. 1085/2003 outline the procedures for processing variations to marketing authorisations granted via National and Community procedures, respectively. The Annexes to the regulations provide criteria for categorisation of changes. 

The EU will accept applications without supporting pre-clinical and clinical data, if it can be demonstrated that the active substances have been in well-established medical use in the Community for at least 10 years, with recognised efficacy and an acceptable level of safety. This route would be appropriate for many common over-the-counter (OTC) products. Safety and efficacy is supported by providing copies of published scientific literature as part of the submission that is, the submission relies on safety and efficacy data available in the public domain, as opposed to confidential data from authorised applications that is the cornerstone of generic applications. 

Council of European Communities, Directive 89/107/EEC, December 21, 1988, on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption, 1988. 

Volume 2A Notice to applicants—Medicinal products for human use—Procedures for marketing authorisation Volume 2B Notice to applicants—Medicinal products for human use—Presentation and content of the dossier Volume 2C Notice to applicants—Medicinal products for human use—Regulatory guidelines Commission of the European Communities, Luxembourg, 1998/1998/ 1999 (and amendments)... 

REACH Registration Evaluation, Authorisation and Restriction of Chemical Substances (European Community Regulation on chemicals and their... 

European Commission (2004) Decision 2004/248/CE of 10 March 2004 concerning the noninclusion of atrazine in Annex I to council directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing this active substance. Official Journal of the European Communities... 

However, if the raw materials are contaminated or the composting process is incomplete, unfavorable effects must be expected. Heavy metals may be introduced into the compost with communal waste. To ensure that these do not enter the food chain, authorised limit values must be strictly adhered to. The same is true of organic contaminants (particularly polyaromatic or chlorinated hydrocarbons), the effect of which is extremely complex. If the fermentation process is not satisfactory, putrefaction will occur, the by-products of which (S02, NH3, N02, organic acids, cadaveric alkaloids, etc.) inhibit plant growth and attract pests. 

Raw materials or goods which are exported to the USA are subjected to the same restrictions as those which are manufactured within the USA. There is also a duty to ensure that each delivery is authorised by the US customs authorities. Anybody who does not conform to these so-called TSCA (Toxic Substances Control Act) conditions must reckon on a high fine. This article examines in detail all the legal, administrative and financial steps that must be followed before making the first exports, including adhesives. EUROPEAN COMMUNITY EUROPEAN UNION GERMANY USA WESTERN EUROPE... 

The European Commission has adopted a directive which limits the emission of volatile organic compounds due to the use of organic solvents in certain industrial activities. The directive sets emission limits for these compounds and lays down operating conditions for industrial installations. In addition, under the directive, new installations must be registered or be authorised to carry out their activities. Further requirements of the directive are listed. EUROPEAN COMMUNITY EUROPEAN UNION WESTERN EUROPE-GENERAL... 

Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the member states concerning food additives authorised for use in foodstuffs intended for human consumption (Official Journal of the European Communities (L40) of 11 February 1989, pp. 27-33), as amended by Directive 94/34/EC of 30 June 1994 (OJ (L237) of 10 September 1994, pp. 1-2). 

Antioxidants should be labelled on the retail package with the specific chemical name or with the EC number. The legislation of member states of the EU is influenced by the decision taken within the EC. Some food standards are fully based on EC Directives and some are still based on national considerations. There may be differences between European states, for instance, the utilisation of ascorbic acid as antioxidant for egg products is permitted in France but prohibited in Germany. These differences concern usually the utilisation of antioxidants in various food commodities. The specification of antioxidants mentioned in EC Directives are respected by all member states. But it is still generally required that individual countries of the European Union as well as the central organisation should be approached. The requirements appearing in the EC Directives on additives must be applied by the member states. This means in the first place that for those categories of additives for which a Community positive list exists, member states may not authorise any additives which do not appear on the positive list. 

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Off J Eur Union L136 l-33... 

This is the name of what we used to know simply as the data sheet, or colloquially as the package insert. The SPC is the document that must be submitted in draft by companies to the MHRA/Reference Member State/European Medicines Evaluation Agency upon application for a marketing authorisation and, once approved, must then be provided to prescribers or suppliers of medicines, either with the product or at the time of promotion or within the previous 15 months of promotion of the product, written or verbal. The SPC includes the prescribing information for the product and represents the product licence approval for the medicine (see Section 12.2.1.1). It is the definitive statement between the competent authority and the company and, more importantly, is becoming the common basis of communication between the... 

Patent protection under general law usually lasts for up to around 20 years. This creates a difficulty in relation to medicinal products, as it can take some 12 years for the products to undergo research, development, the extensive clinical trials that are required in order to obtain a marketing authorisation and the authorisation process itself. These steps are also extremely expensive. The amount of time that remains during which the patent holder can exploit his patent and recoup his massive investment can be severely curtailed in relation to medicinal products. For this reason, the European Community has provided a form of additional patent-related protection for medicinal products authorised within the European Community, by means of a Supplementary Protection Certificate. A patent holder may apply for a certificate that takes effect at the end of the term of the basic patent, for a period equal to the period that elapsed between the date on which the application for the basic patent was lodged and the date of the first authorisation to place a product derived from the patent on the market in the Community, reduced by a period of 5 years. The maximum duration of the certificate is 5 years. The certificate applies to all medicinal products derived from the basic patent, but the additional time that can be obtained under the SPC is calculated in relation to the first product derived from the patent, authorised in the EU. 

In the European Union, a medicinal product may only be placed on the market when the competent authority of a Member State for its own territory (national authorisation) has issued a marketing authorisation or when the European Commission (EC) has granted an authorisation for the entire Community (Commimity authorisation). 

Regarding all activities for the regulation of pharmaceuticals at the EU level. Article 71 of Regulation EEC/2309/93 that established the EMEA and the CPMP required that Within 6 years of the entry into force of this Regulation, the Commission shall publish a general report on the experience of the procedures laid down in this Regulation, in Chapter 111 of Directive 75/319/EEC and in Chapter IV of Directive 81/851/EEC. The tender for review was awarded to a consortium of Cameron McKenna and Arthur Anderson. The full report from Cameron McKenna, dated October 2000 and entitled Evaluation of the Operation of Community Procedures for the Authorisation of... 

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