National registration

Netherlands drug regulation now follow European Union rules. For example, GMP inspection is based on the 1983 European Union guidelines for GMP. Since 1 January 1995, a European procedure for registration has operated in the Netherlands. Now two types of trade licences exist a European licence and a national licence. Products with a European licence may be sold throughout the whole European Union, while the national licences are only valid for the country in which the licence was issued by means of the national registration procedure. 

Landelijke Registratie Evaluatie Bijwerkingen [National Registration and Evaluation of Adverse Drug Events] (Netherlands)... 

Nevertheless, such special study protocols should be discussed with those regulatory authorities which are involved in the national registration and/or EU evaluation in advance. 

Reformatting of the final report to comply with the submission requirements of a national registration or regulatory authority does not constitute a correction, addition, or amendment to the final report. 

As crime rates continue to increase, the President s Commission on Law Enforcement includes among its recommendations national registration of handguns and the prohibition of interstate sales of handguns. 

The National Commission on the Causes and Prevention of Violence issues a report that includes recommendations for laws for the national registration of handguns and the licensing of handgun purchasers. 

Elvin, John. The Thinning Ranks of America s Gun Dealers. Insight on the News, vol. 13, April 7, 1997, p. 23. Reports that there are 100,000 fewer gun dealers, and argues that ever more strict gun laws are the reason. Elvin describes a number of proposals that would go beyond the Brady Bill in increasing paperwork and expense for gun dealers and that could lead to a national registration system that would facilitate gun confiscation. 

Anonymous, Report of the Working Party on Residues of Long Acting Antibiotics at Injection Sites. National Registration Authority, Camberra, Australia (1995). 

An additional factor in the high level of noncompliance is that the Australian MRLs in offal (0.05 mg/kg for chlortetracycline and 0.25 mg/kg for oxytetracycline) are significantly lower than those now recommended by Codex Ali-mentarius (0.60 mg/kg for both compounds). Thus, the registration data, withdrawal periods, and MRLs for these compounds are currently being reviewed by the responsible bodies in Australia, namely the National Registration Authority and the Australia New Zealand Food Authority. 

APVMA (formerly the National Registrations Authority for Agricultural and Veterinary Chemicals) (November 1997). The NRA review of atrazine. 

National Registration Authority for Agriculture and Veterinary Chemicals of Australia (November 1999). The NRA review of atrazine existing chemical review program. 

In conclusion, all the new systemic fungicides against Oomycetes had an immediate need for mixing partners. It can be assumed that this will also hold true for future systemic fungicides. This use concept calls for flexibility both on the part of industry, national registration authorities, and the extension services to make safe and powerful products available for plant protection. 

In August 1992, the Commonwealth announced that it would establish a National Registration Authority for Agricultural and Veterinary Chemicals (NRA) to undertake registration activities, with associated policy issues being the responsibility of the Department of Primary Industries and Energy. 

Guideline specifications for household insecticide products — mosquito coils, vaporizing mats, liquid vaporizers and aerosols, were drafted at a WHO informal consultation, held in Geneva from 3 to 6 February 1998 (6). The draft guidelines have been distributed to ministries of health and national registration authorities for comments and suggestions. 

The Committee recommended that industry ensure that containers for public health pesticides meet the following design characteristics and satisfy the needs of national registration and approval systems. 

The harmonization of the national legislation on pharmaceutical products in the EEC is well advanced and covers almost all aspects. Although national registrations are still possible and the EEC-wide... 

The EPA s strategy includes a national registration of pesticides and state-directed management by monitoring and pesticide use restrictions based on local groundwater conditions. 

This chapter provides a brief overview of the new European pharmaceutical registration system and aims, in particular, to act as a point of cross reference from the chapters on the national registration systems of the individual member states (MS) of the European Union (EU). Further information may be obtained through the internet at http //www.Heads.medagencies.org/html. 

For larger companies, the Europecin centralised/multistate procedure will be the only option in order to penetrate the markets with new products as quickly as possible. The fees for this procedure are very high, which is a deterrent to smellier companies since this procedure would be a major investment for them with a small chance of a successful outcome. The procedure is complicated and very formal, which mcdces it difficult for small companies to cope with the requirements. Thus the national registration procedure remains an attractive alternative for smaller companies since the market size is still big enough, even for products with a modest degree of innovation. 

In order for a pharmacy to receive IDA or TSDA for sale or use within the pharmacy they must apply to ffM Revenue and Customs National Registration Unit in order to gain authority to receive (see Figure 10.6). Authorisation must be obtained before a supply of IDA or TSDA can be made. Once authorisation has been granted, a copy of the authorisation must be sent to the supplier and then a supply may be made. 

The mutual recognition procedure (or the decentralised procedure ), which is in essence a national registration recognised by the other member states. 

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