- Resolution on the Facilitation of Marketing Authorizations
The Ministry of Health has established an expedited procedure for the marketing authorization and post-approval changes of medicines previously approved by WHO-listed authorities (WLA).
Key aspects:
- Scope of application: Medicines authorized by WLAs and post-approval changes equivalent to RTCA 11.03.59:18.
- Exclusions: Not applicable to homeopathic medicines, radiopharmaceuticals, or natural medicinal products.
Resolution timelines:
- Marketing authorizations: up to 6 calendar months.
- Post-approval changes: up to 45 calendar days.
- Procedure: Applicants must submit a digitally signed statement of intent to [email protected].
- Repeal: Resolution MS-5917-2024 is hereby repealed.
- Ban on CMR Substances in the European Union
As of September 1, 2025, the use of Trimethylbenzoyl Diphenylphosphine Oxide and Dimethyltolylamine, classified as carcinogenic, mutagenic, or toxic for reproduction (CMR), is prohibited under Regulation (EU) 2025/877.
Implications in Costa Rica:
- The Ministry of Health requires manufacturers, importers, distributors, and cosmetic industry professionals to review the composition of marketed products.
- A one-month period, starting on September 11, is granted to withdraw products containing these substances from the market.
- After this period, measures may be imposed under Article 356 of the General Health Law, including cancellation of marketing authorization, seizure, and product withdrawal.
For further information on these regulatory updates, please contact our team at [email protected].