how to make a thumbnail for youtube croat cro

Medicines that are granted a marketing authorisation by the European Commission can be marketed throughout the EU. Today, the great majority of new, innovative medicines pass through the centralised authorisation procedure in order to be marketed in the EU. whose authorisation would be in the interest of public or animal health at EU level.that are a significant therapeutic, scientific or technical innovation.containing new active substances for indications other than those stated above.veterinary medicines for use as growth or yield enhancers.

orphan medicines (medicines for rare diseases).

advanced-therapy medicines, such as gene-therapy, somatic cell-therapy or tissue-engineered medicines.

medicines derived from biotechnology processes, such as genetic engineering.

auto-immune and other immune dysfunctions.

human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS).

human medicines containing a new active substance to treat:.

The centralised procedure is compulsory for: Once granted by the European Commission, the centralised marketing authorisation is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.Ĭommission decisions are published in the Community Register of medicinal products for human use. The European Commission is the authorising body for all centrally authorised product, who takes a legally binding decision based on EMA's recommendation. This decision is issued within 67 days of receipt of EMA’s recommendation. However, under EU law EMA has no authority to actually permit marketing in the different EU countries. This allows the marketing-authorisation holder to market the medicine and make it available to patients and healthcare professionals throughout the EU on the basis of a single marketing authorisation.ĮMA's Committee for Medicinal products for Human Use ( CHMP) or Committee for Medicinal products for Veterinary Use ( CVMP) carry out a scientific assessment of the application and give a recommendation on whether the medicine should be marketed or not.

Under the centralised authorisation procedure, pharmaceutical companies submit a single marketing-authorisation application to EMA.

How to make a thumbnail for youtube croat cro