Licences production

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. 

Manufacturing Premises licence Manufacturing licence Product manufacturing licence 217-362 125... 

Commercial manufacture of this polymer was first announced by CdF Chimie in 1975 following about 10 years of study on the Diels-Alder reactions of alkenes with cyclopentadiene. In 1976 a plant with a capacity of 5000 tonnes per annum was put on stream and product marketed as Norsorex. Manufacturing under licence is now being extended to American Cyanamid whilst CdF Chimie has also signed a marketing agreement with Nippon Zeon. 

By this time, the product had proved, in continuing toxicity and feeding trials, to be safe and effective feed material.The process was patented and the trade name Pruteen given to the product A licence to sell the product as feed was granted by the Ministry of Agriculture, Fisheries and Food. 

There is no point marketing a product until you have a sales licence. However you need to market the product at pilot-scale, to establish the market before you begin full-scale production. 

Figure 7.10 Outiine of requirements for a Veterinary Bioiogics Product Licence Appiication.

In all 10 countries, licensing of manufacturing, product assessment and registration, GMP inspection, import controls and control of product quality are determined by legislation. Licensing of importation and wholesale trade is not required in Cuba and Cypms, however. In Zimbabwe, a licence is required for wholesale trade. 

A manufacturing licence is issued for each product, rather than to the manufacturer. Pharmacies do not need a formal licence, but must register with the Healthcare Inspectorate. Dispensing physicians must be licensed. 

Estonia Regular contacts Information on registered products and licence on website Quarterly annual report Violations of drug promotion standards publicized on website... 

The absence of mandatory manufacturer licensing in Cypms is believed to be a factor in the establishment of small packaging units to bypass price-fixing procedures. Moreover, the procedure for issuing a licence to manufacture a product is, to a certain degree, retrospective, since the application is submitted after the manufacturer has built the facility. Ensuring that any requested modification of the facility is carried out is therefore difficult. 

Unrenewed/expired licence Counterfeit products Illegally imported products Expired products being sold Unregistered products on the market Products stored under improper conditions... 

If the process used has not been developed exclusively by the operating company, royalties and licence fees may be payable. These may be paid as a lump sum, included in the fixed capital, or as an annual fee or payments based on the amount of product sold. 

The mutual recognition procedure is an alternative means by which a marketing authorization may be sought. It is open to all drug types except products of biotechnology. Briefly, if this procedure is adopted by a sponsor, then the sponsor applies for a marketing licence not to the EMEA, but to a specific national regulatory authority (chosen by the sponsor). The national authority then has 210 days to assess the application. 

If adopted by the national authority in question, the sponsor can seek marketing licences in other countries on that basis. For this bilateral phase, other states in which marketing authorization are sought have 60 days in which to review the application. The theory, of course, is that no substantive difficulty should arise at this stage, as all countries are working to the same set of standards as laid down in The Rules Governing Medicinal Products in the European Union . 

Pre-approval safety and efficacy clinical studies involved product administration to 2500 adults with either type-1 or -2 diabetes. The primary efficacy parameter measured was glycaemic control (as measured by the reduction from baseline in haemoglobin Ale). Hypoglycaemia was the most commonly reported adverse effect. Trials also showed a greater decline in pulmonary function in the Exubera group, and product should not be administered to patients with underlying lung disease, or to smokers. Exubera was developed by Nektar Inc. and is marketed under licence by Pfizer. 

Small quantities of hazardous solid wastes (such as potassium dichromate, lead nitrate, silver nitrate, asbestos, etc.), liquid chemicals (such as chloroform, PCB, methylene chloride, etc.), petrochemicals (such as gasoline. No. 2 fuel oil, etc.), or pure metals (such as mercury, sodium, etc.), which are stored in bottles or cans, however, are not considered to be hazardous household products. Accordingly these nonhousehold hazardous solid wastes, even in small quantities, can only be properly disposed of by licenced or certified environmental professionals. 

Before the market launch of the product, regulatory authorities will inspect the production premises and processes to ensure that everything complies with the licence application and GMP. GMP must be maintained throughout the production cycle, including, where required, suppliers and also the distribution chain. In fact. 

As discussed in the introduction to this chapter, results of ED are intended to give a clear indication that the drug is a serious candidate for FD to product licence, or that it is not viable and development should be stopped forthwith. Sometimes it takes a little longer before the picture becomes clear but the aim should be to make a go/no-go decision at the earliest opportunity. 

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