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What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?

There are several post-market monitoring mechanisms associated with marketing authorisation that are regulated within various regulations. Having said that, the main obligations of a marketing authorisation holder before the Pharmaceuticals and Medical Devices Agency regarding the possessed authorisation include:

  • manufacturing of the product as per agency specifications and scope of the approved marketing authorisation;
  • making approval submissions to the agency for every change required for considering scientific developments, manufacture and control of products in well-accepted methods;
  • updating the summary of product characteristics and instructions for use, if necessary;
  • fulfilling essential responsibilities within the scope of pharmacovigilance practices (although pharmacovigilance services can be outsourced, the marketing authorisation holder still remains responsible);
  • making the products available in the market; and
  • complying with all applicable laws and regulations in its activities (eg, promotional operations).

Data protection

What data protection issues should be considered when conducting pharmacovigilance activities?

Pursuant to the Regulation on the Safety of Medicines, when conducting pharmacovigilance activities, the identification and address of the patient and the healthcare provider notifying the Pharmaceuticals and Medical Devices Agency will be kept confidential within the notifications. This information will not be declared to third parties, other than the Pharmacovigilance Centre personnel, without their consent. The marketing authorisation holders, health institutions and organisations and healthcare providers must comply with these confidentiality principles.

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