Registration decisions

There is an appeals system for resolving disputes about registration decisions in each of the 10 countries. Some countries have a number of levels of mechanism for the... 

Compliance wifii laws regulating pesticides consideration of input from all stakeholders makes decision to register or reregister the pesticide based on risk assessment and benefits analyses makes decision on mitigation measures necessary to support registration decision Preparation of a scientifically valid risk assessment... 

Technical experts with responsibility for communicating results to regulators, registrant-decision makers, and others Assists in communication to regulators, and other stakeholders — understanding of risk assessment necessary... 

USEPA (2009) List of Reduced Risk/ Organophosphate Alternative Registration Decisions for Conventional Pesticides, Updated 1 July 20(f) http //www.epa.gov/ opprdOOl/workplan/completionsportrait. pdf (30 April 2010). 

The third major cateory of information that must be included on pesticide labels encompasses a variety of topics that fall under the general heading of Directions For Use. As noted very early in this chapter, pesticides are registered on the basis of their uses against specified pests and for specified crops. The use directions are, in fact, the practical embodiment of the EPA s registration decision. 

Practically in all European comtries the key role in the administrative handling of applications for registration lies with offices of the Ministries of Agriculture. They accept the applications, organize the involvement of experts of the Ministries of Health and Ministries or Agencies of Environment, and they issue the final registration decisions. These decisions are often reached in an interministerial special commission which may include experts from academia, or even industry. 

ASME uses quality system auditors experienced in the above-listed fields who have been certified to the international auditor qualification standard ISO 10011-2. Registration decision and policy making are conducted within the firamework of the ASME codes, standards, accreditation, and certification committee structure. The use of volunteers from industry and government provides for a high quality program that is administered in a fair, impartial, and professional manner. 

Depending on the circumstances, seemingly descriptive marks when taken as a whole might constitute only suggestive terms. A 1968 decision of the Court of Customs and Patent Appeals is illustrative. Sugar and Spice was held registrable for bakery goods. The court stated ... 

If no opposition is filed, or if a decision favorable to the appHcant is made in an opposition, the appHcation is allowed, and the registration is... 

Whilst the decision to pursue ISO/TS 16949 registration will be an executive decision, the attention it is given at each level in the organization will have a bearing on the degree of success attained. There are three primary organization levels the enterprise level, the business level, and the operations level. Between each level there are barriers. 

In Malaysia, interference from the outside, political or otherwise, regarding decisions of the regulatory authority is rare. A recent exception was the debate over the registration of sildenafil (Viagra ), for the treatment of erectile dysfianction. 

Registration requirements, SOPs and decision criteria are documented to ensure transparency of the regulatory process and to facilitate communication between the regulatory authority, the pharmaceutical industry and the public. 

In Estonia, however, as many as 17% of the applications are withdrawn Ifom the process. Rejection rates are highest in Venezuela and Malaysia (30% and 29%, respectively). In both countries, withdrawal rates are small (0% and 3%, respectively). In Australia in particular, the number of applications withdrawn before a final decision has increased significantly in the past four years. This increase in withdrawals is probably a result of the way in which the registration system now operates, with a proposed decision to reject being made by the Delegate, prior to obtaining formal advice from the Australian Dmg Evaluation Committee. 

This section examines the amount of time taken to register a pharmaceutical product— i.e. from the time an application is submitted to the time when the final decision is reached—and attempts to clarify how workload and fees affect registration time. 

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