Bosnia & Herzegovina
- Regulatory Authority:
The Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina
- Legislation:
Official Gazette of B-H, no.58/08
- Registration period:
90 days
- Certificate validity period:
5 years
- Language of labeling and documentation:
Bosnian, Croatian, Serbian
- Authorized Representative:
country resident
- Special requirements:
- Audits: An audit by a notified body is required
- Technical Local Tests: no local testing requirements
- Clinical Evaluation/studies: no clinical evaluation studies required