Product licence application , regulation

Regulations for the renewal of Registration Certificates for human use of pharmaceutical products were established by the CDMDR on 13 February 1997 and published in the Polish Pharmaceutical Journal. Renewal applications should be submitted for all products licenced before 1 January 1994 and those with expiry date of 31 December 1997. In the future applications for renewals should be made not later than six months before expiry date. Registration Certificates ending by 31 December 1997 were exempted from the rule. 

Fees are levied in respect of applications for MAs, Manufacturer s Licences, Wholescile Dealer s Licences, Clinical Trial Certificates, and variations thereto inspections of manufacturing sites annual maintenance fees and issue of export certificates. No fees are levied in respect of applications for exemption from a Clinical Trial Certificate, so-called CTX applications, or for MA renewcils. The fees are based upon the statute SI 1995 No. 1116 The Medicines (Products for Human Use-Fees) Regulations as eimended, and for 1999/2000 are summcu-ised in Table 7. 

The UK Medicines Act (1968) places responsibility on the applicant for a licence, which in most cases is a company, not on an individual within the company. The legal responsibility is thus that of the company to comply with the various regulations under the Act. Under certain circumstances, the regulatory authority (i.e. the government), may be sued if it was allegedly somehow at fault in granting or failing to withdraw a licence for the product that supposedly caused harm . 

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