Health registration certificates
Initial validity is five years; each renewal lasts ten. If renewal is not requested on time, COFEPRIS cancels the registration.
Registration
An expired health registration stops product sales.
The most important and highest-risk documents for the pharmaceutical industry.
Health registrationexpires in 45 daysExpiring soon
Health officer noticepermanentCurrent
Advertising permitpermanentCurrent
Where the risk lies
Pharmacovigilance reports
Losing this trail creates significant legal risk.
Product
Health license
For the factory or warehouse. It does not expire but can be revoked for noncompliance and ceases to apply after a change of address.
Product
Advertising permits (COFEPRIS)
Required to advertise health products. Published advertising must match the authorization.
Distribution
12 critical documents, grouped by the risk they address
Alongside the corporate foundation every company needs in order: incorporation deed and bylaws, corporate books and notarial powers of attorney.
Health Registrations
- Health Registration CertificatesAuthorization to sell a medicine or medical device. Initial validity is five years, with ten-year renewals. Applications from the second renewal onward must be filed at least 150 calendar days before expiry, or the registration is canceled.
- Product DossierClinical and technical studies that must be available for audits.
- Free Sale Certificates (CLV)Required to export products to other countries.
Operating Licenses and Notices
- Health LicenseSpecific to a factory or storage and distribution warehouse. It does not expire but can be revoked for noncompliance and ceases to apply after a change of address.
- Health Officer NoticeThe document identifying a qualified professional, such as a chemist or physician, as legally responsible for quality before the authority.
- Advertising PermitsCOFEPRIS authorizations to advertise health products, granted for an indefinite term. Published advertising must match the authorization.
Quality Management and Pharmacovigilance
- Standard Operating Procedures (SOPs)Instructions for each operation. NOM-059 requires approval, signatures, dates and periodic review, verified by the health authority.
- Pharmacovigilance ReportsRecords of adverse reactions. Losing this trail creates significant legal risk.
- Input Supplier AuditsDocumentation demonstrating that raw materials come from certified sources.
Intellectual Property and Contracts
- Patent and Trademark CertificatesProtection for the formula or trade name.
- Third-Party Manufacturing AgreementsWhere another company manufactures the medicine.
- Non-Disclosure Agreements (NDAs)Strict confidentiality requirements protecting formula trade secrets.
Which documents does COFEPRIS require from a pharmaceutical company?
Current health registrations (five years initially, with ten-year renewals), a health license, health officer notice, advertising permits and pharmacovigilance reports, among others. Losing track of any creates legal and operational risk.
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Pharmaceuticals
12 critical documents
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