Our Law Firm provides comprehensive assistance in solving legal problems related to drug registration in the broad sense of the term.
Drug registration is not essentially a preserve of a lawyer since it requires engineering and pharmaceutical expertise. However, serious legal problems can also occur in this area, requiring consultation with a lawyer. Below are examples of problems we have encountered recently. They concerned, among others:
- application of the sunset clause principle,
- disputes with registration authorities under the decentralized or mutual recognition procedure,
- the existence or absence of an obligation to disclose certain production sub-processes (determination of samples, holiday sets, etc.) during the registration,
- performance of the obligation to carry out safety or efficacy tests after the product is marketed (PASS, PAES),
- disputes with administrative authorities regarding the obligation to change the registration indications for medicinal products or to add warnings, etc.,
- the course and holding positions within the so-called referral proceedings before the CHMP, EMA and the European Commission.