Notification of changes of conditions
The manufacturer of active substances must within seven days notify the relevant authority on any modification of conditions that the manufacturer of active substances for the entry in the register of manufacturers of active substances must fulfil (appropriate staff, premises, devices and equipment, the consideration of good manufacturing practice guidelines), i.e. which has an important impact on the quality or safety of the manufactured active substance.
The competent authority enters the notified change in the register of manufacturers of active substances:
- based on the opinion of the expert committee on establishing the fulfilment of conditions for the manufacture of active substances in 90 days by issuing a certificate
- or entering the change under the previous paragraph in the register of manufacturers of active substances in 30 days from the date of the receipt of the complete application if the committee assesses that the verification of the fulfilment of conditions is not necessary and issues an appropriate certificate.
If the change under the first paragraph of this article does not refer to data from the register of manufacturers of active substances, the competent authority issues a decision on the assessment of the fulfilment of conditions for manufacturing active substances in 30 days or in 90 days from the date when a complete application is received, if the committee assesses that the verification of the fulfilment of conditions is required.
If the expert commission under the previous paragraph issues a negative opinion on the change of the fulfilment of conditions for manufacturing active substances, the competent authority does not enter it in the register of active substances by issuing a decision.
- Judicial remedy: Appeal
- Competent authority: Ministry of Health