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Application for submit administrative information for marketing authorisation of medicines


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Use terms


It's essencial to know the real situation of medicine marketing to inform health professionals and facilitate the prescription. That’s why the AEMPS requires the holders of marketing authorisations of medicines to keep updated the information on availability of each presentation of medicine, both to notify when they bring to the market the first batch as to communicate the annual marketing intention.

This application allows these telematic procedures with the AEMPS:



Inform about the annual marketing plans

The holder of the marketing authorisation of a medicine will fullfil his obligation to make the annual declaration of MARKETING PLANS using this telematic service. The period for submitting this statements is a month and will starts in October of the previous year.

For each medicine with marketing authorisation the holder must indicate which formats are currently available and which ones remains without marketing. The laboratory should also indicate whether he intends to request the suspension or cancellation on market of the medicine in the next year.

Communicate the bring to the market of the first batch.

Procedure applies only to medicines with authorization approved after October 13th, 2007, date in which starts applying RD 1345/2007.

The owner should announce the date on which the first batch of the medicine is available in pharmacies. From that date the medicine must be available in the market without disruption and the laboratory must notify the AEMPS any supply problems or any plans to stop selling the product at least two months before doing it.

The holder shall specify which of the presentations authorized will be on the market and which ones remain out of market.nd which ones remain out of market.

Update information on formats available on the market

In order to keep the information provided by the AEMPS to citizens and health professionals reliable and reflect the current situation of medicines and presentations in the market, the laboratories must keep updated the information on the marketing of the different presentations of a medicine through this option of the application.

This option may be used at any time and independently to communication processes of the first batch or annual declaration of marketing.

Manual


Application Access


Access to the application will be done using the same user / password used to access RAEFAR.

Application: https://sinaem.agemed.es/WebComercializacion/login.aspx?opc=humana

If you don’t have username and password, you can request it using the form available in this Virtual office.

Once authenticated the user and determined the laboratory you’ll get the list of medicines owned by the laboratory, but not those of which the laboratory is the local representative if the ownership is from another company.