Informative Notice
Certain content is still being edited. Thank you for your understanding.
Responsible person for pharmacovigilance system
The holder of the marketing authorisation must have a permanently available person responsible for the pharmacovigilance system who is responsible for the establishment and maintenance of the pharmacovigilance system. The person responsible for pharmacovigilance system:
is responsible for the establishment and maintenance of the pharmacovigilance system to ensure the collection and comparison of data on all suspected adverse reactions of the medicinal product; has ensured access to the main dossier on the pharmacovigilance system and sufficient jurisdiction for ensuring that the content of the main dossier on the pharmacovigilance system is accurate and regularly updated to reflect the needs of the pharmacovigilance system; has sufficient jurisdiction to impact the implementation of the quality system and pharmacovigilance activities; has an overview of the safety profiles of medicinal products and safety issues and considers as well as monitors the conditions of launching medicinal products and other obligations that affect the safety of medicinal products and the measures for reducing risks; has sufficient jurisdiction with regard to the content of risk management plans, cooperates at the review and approval of protocols of clinical trials after acquiring the marketing authorisation; ensures appropriate quality, accuracy and completion of data on the pharmacovigilance of the medicinal product that are submitted to the competent authority and to all requirements of the competent authority to submit additional data required for assessing benefits and risks connected with the medicinal product, replies in entirety and immediately and submits data on sales; submits all other information relevant for the assessment of benefits and risks connected to the medicinal product to the competent authority, including appropriate data from clinical trials after obtaining the marketing authorisation; guarantees 24-hour availability; has appropriate education, knowledge and skills.
Conditions
-
The person responsible for pharmacovigilance must have a suitable education, knowledge and experience in the field of pharmacovigilance.
Appropriate education denotes:
- secondary level of education in medicine for medicinal products for human use or another compliant level of education as per the law;
- and a secondary level of education in veterinary medicine for medicinal products used in veterinary medicine or another suitable level of education as per the law.
If the person responsible for the pharmacovigilance system has not had a suitable education, they must be given a permanent and continuous opportunity to acquire expert support from a person with a suitable education.
Evidence
Diploma: certified or non-certified copy and the original provided on request. Certificate of knowledge and experience in the field of pharmacovigilance
Legal basis
-
The person responsible for the pharmacovigilance must reside and operate within the borders of the European Union.
Evidence
Certificate of permanent or temporary residence
Legal basis
-
The person responsible for pharmacovigilance must ensure they are available 24 hours per day.
Legal basis
Recognition of qualifications acquired abroad
There are following systems for the recognition of professional qualifications acquired in the EU: