Regulatory Affairs and Pharmacovigilance

Regulatory Affairs

Sidefarma's Regulatory Affairs team ensures compliance with legal and regulatory requirements regarding medicines, food supplements, medical devices and cosmetic and body care products.

In general, the department is in charge of:

  • Obtaining Marketing Authorizations for the medicines the company markets;
  • Maintenance of Marketing Authorizations (renewals, variations to the terms of the M.A. ...);
  • Regulatory support related to own or customer products.

The objective of the Regulatory Affairs team is to provide a quality service, always aiming at continual improvement of the work developed.



Medicines (or drugs) have brought extraordinary benefits, however, they are not without risks and some patients may experience side effects.

Some side effects and risks associated with the use of medicines will only be discovered when the medicine is used by a large number of patients during clinical practice.

For this reason, monitoring and reporting side effects is very important and spontaneous reporting takes on a fundamental role. Pharmacovigilance is essential for a safer and more effective use of medicines.

The deeper and the more detailed knowledge of medicine and their associated risks is, and the information is shared in a timely manner with patients and healthcare professionals, the safer it will be used.

The participation of every single one of us, as citizens, as patients, as health professionals is essential.

Always pay special attention to:

  • Adverse event (described or not in the SmPC)
  • Death
  • Congenital changes
  • Lack of efficacy / worsening of the disease
  • Medication / abuse / addiction / withdrawal errors / off-label use
  • Drug interactions
  • Exposure during pregnancy / lactation or parental exposure
  • Occupational / accidental exposure
  • Unexpected benefit
  • Quality complaints / requests for medical information associated with pharmacovigilance

Always notify, for your health and for the health of all patients.


How to notify?

Pharmacovigilance contacts at Sidefarma:
Pharmacovigilance Departament
+351 219 426 100
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Infarmed, I.P.
+351 217 985 209
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