Establishment Licence Application

CBER refusal to file (RFT) guidance for product and establishment licence applications (7/93)... 

Establishment licences can be amended when any information provided is altered, for example, when a new drug is added to the portfolio, a new dosage form and so on. Changes to any information provided in the origincil or the amending application has to be reported within 15 days. 

The format and content of documents submitted to the regulatory body by the operating organization in support of a licence application shall be based on the requirements established in paras 3.6-3.10. The regulatory body may request additional information, depending on the regulatory practices of the particular Member State. 

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. 

If the employer is not interested in making use of the invention, the inventor is usually free to file a patent application himself and at his own expense. Otherwise, the employer will act as applicant, in which case it is most likely that a legal/patent/licence department and a patent attorney will provide the necessary support. Many universities and government funded institutes have established independent groups, departments or even companies in order to commercially exploit the inventive potential - especially in biotechnology - directly. These organizations may also provide service and advice in patenting. 

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. 

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