Third countries

Excipients should be listed in the composition using their Ph Eur name (or one from another national pharmacopeia from an EEA member state), the International Nonproprietary Name, or an exact scientific designation, other than for materials such as preservatives or coloring agents which can be identified by an E-number. Third country pharmacopeial names may be acceptable. Coloring matter is subject to the provisions of specific legislation in the EEA. 

Where there is a Ph Eur or national pharmacopeial specification for the excipient, this should be applied. Third country pharmacopeial specifications may also be acceptable. Routine tests and specifications should be stated. Function-related specifications should be included. 

This is the standard grade used by small bakers to make bread. There will be sufficient third country wheat, probably Canadian, for it to work in a long process such as bulk fermentation. The protein content would be around 12%. 

In Europe, Spain is the third country - after Germany (18) and France (10) -as regards the number of chlor-alkali plants, with a total of nine. Nevertheless, Spain is ahead along with Germany, in respect to the number of plants (8) which are still using Hg-electrolysis technology. The membrane technology represents... 

In the European Community (EC), the use of hormonal substances for the promotion of animal growth is prohibited (Directive 96/22/EC). The ban was applied without discrimination internally and to imports from third countries as from January 1,1989. As a result, countries wishing to export bovine meat and meat products to the EC were required either to have an equivalent legislation or to follow a hormone-free cattle program [14]. 

The negotiating team will most often include US representatives who act on the US client company s behalf. It is clear, however, that the Chinese are reluctant to have American sellers or buyers represented by third-country parties. The Chinese prefer to deal with Americans representing American products and American companies. They are interested in learning about our thought processes, our marketing practices, our corporate management skills, as well as about our products, services and technology. Yet they have a sense of humor not unlike ours. 

In early 2007, the EMEA reported the analysis of GMP deficiencies in its document entitled Good Manufacturing Practice An Analysis of Regulatory Inspection Findings in the Centralised Procedure. It detailed the deficiencies reported in 435 inspections of manufacturers of medicinal products and starting materials in the European Union and third countries in the period 1995 to 2005. Altogether there were 9465 deficiencies, of which 193 were critical (2%), 989 major (10%), and 8283 (88%) others. The top 20 deficiencies are presented in Table 10.1. 

Member States shall ensure that appropriate information about action taken pursuant to paragraphs 1 and 2 which may affect the protection of public health in third countries is forthwith brought to the attention of the World Health Organisation, with a copy to the Committee. 

Regulation (EC) No 540/95. Commission Regulation (EC) No 540/95 of 10 March 1995 laying down the arrangements for reporting suspected unexpected adverse reactions which are not serious, whether arising in the Community or in a third country, to medicinal products for human... 

In order to achieve optimum protection of health, obsolete or repetitive tests will not be carried out, whether within the Commimity or in third countries. The harmonisation of technical requirements for the development of medicinal products should therefore be pursued through the appropriate fora, in particular the International Conference on Harmonisation. 

Subject to any arrangements which may have been concluded between the Community and third countries, the Commission, upon receipt of a reasoned request from a Member State or on its own initiative, or a Member State may propose that the trial site and/or the sponsor s premises and/or the manufacturer established in a third country undergo an inspection. The inspection shall be carried out by duly qualified Community inspectors. 

In the third country, roller compaction was substituted for the slugging process. While the sizing of the slugs and compacts were completed on different machines, and the particle size results were not exactly the same in each situation, the tablet content uniformity results were equivalent. Content uniformity relative standard deviations of 1.5-2.0% ( = 10 tablets) were routinely achieved. The tablet dissolution profiles averaged 95% or higher within 30 minutes in each country. 

To provide the NRLs within the European Union and third countries with methods of analysis, technical advice, scientific assistance, and to promote and coordinate research into new methods (65). A series of... 

In November, 1985, the Commission submitted to the Council a draft regulation that would ban natural hormones, except for therapeutic purposes, and banned synthetic hormones altogether. In December, 1985, the Commission s proposal to amend Directive 81/602 to prohibit use of anabolics was adopted by the Council and became Council directive EC 85/649. The directive banned the use of natural hormones except for therapeutic purposes and absolutely banned the use of synthetic hormones. The directive also imposed a trade clause that required Member States to prohibit importation from third countries of live animals and of meat from animals to which have been administered in any way whatever substances with a thyreostatic, estrogenic, androgenic, or gestagenic action. Member States were required to bring this directive into force no later than January 1, 1988. 

The concept of adoption of MRLs by reference aims to establish a permanent mechanism under which an importing country with no established MRLs for particular commodity/residue combinations will automatically apply the Codex MRL to relevant imported products. For those situations in which the Codex has not yet established MRLs, the MRL of the exporting country, or that of an agreed third country, would automatically be applied, provided that the MRLs have been determined by scientifically based chemical evaluation procedures. This mechanism already applies in a number of EU countries and is consistent with EU directives. 

The third option outlined in Article 11 (7) provides for an exception in which, at the request of a member state of the EU, an individual inspection body in a third country can be approved following an assessment of that inspection body using appropriate means. This does not necessarily require an on-site inspection of the inspection body. However, this option has seen rather limited use, with just one instance up to mid 2003 (Swedish National Board of Trade 2003). 

The impact of the EU conformity assessment system has been to encourage third countries to adopt the EU regulation, given that in practice they need to demonstrate compliance in order to obtain third country status (Swedish National Board of Trade 2003). Most other countries have followed the EU example and recognise only domestically based certification, except for the USA and Japan that allow foreign certification bodies to apply directly for recognition. 

Enforcement of EC regulations on pesticide residues in foodstuffs is the responsibility of the competent authorities in the Member States. The authorities in each Member State should ensure that the products produced in that country and those imported directly from countries outside the EU ( Third Countries ) comply with EC legislation. In principle, when such a system is fully developed and operational in all Member States, there should be no real need for countries to examine products coming from other Member States. 

January 1992 Commission Regulation (EEC) No. 94/92 Import Describes mechanism for approving a country s entry onto the Third Country list, which accepts production rules and inspection systems as equivalent to those of the EU. The preliminary list was repeatedly amended and implementation delayed. Finally implemented March 1997... 

June 1993 Commission Regulation (EEC) No. 593/93 Delay to implementing the Approved Third Country list Further delays in approving equivalence... 

Removal of an Argentine inspection body from proposed list based on on-the spot-evaluation. Superseded Further delay in implementing the Third Country list and minor change to the import certificate... 

Modified Third Country list of 94/92, delayed implementation until 1 January 1997. Superseded by 314/97 below Indicates finalisation of evaluations and presents Modified Third Country list including addition of a Dutch inspection body as an approved body in Hungary... 

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