Commercial Information Circulars

24-hour hotline : 23 922 922

e-mail address : enquiry@tid.gov.hk

Ref : EIC 426/2

2 January 2014

Dear Sirs,

Commercial Information Circular No. 1/2014

Mexico : Guidelines to Validate Good Manufacturing Practices for Drugs

Mexico's Ministry of Health has recently issued a set of guidelines that are to be followed in validating good manufacturing practices certificates for drugs and medicaments.

DETAILS

2. The guidelines apply to the sanitary registration of allopathic medicines, any modifications to such registrations (if applicable), as well as the extension of such registrations. Registration applicants are required to have a certificate of good manufacturing practices for the drug or medicament in question issued by (i) the Federal Commission for the Protection against Sanitary Risk (COFEPRIS); (ii) a foreign health agency duly recognised by COFEPRIS, namely the U.S. Food and Drug Administration, the Brazilian Health Agency (ANVISA), Health Canada, the European Medicines Agency, Japan's Pharmaceutical and Food Safety Bureau or Australia's Therapeutic Goods Administration; or (iii) the health authority of the country of origin of the goods. An original or notarised copy of the GMP certificate must be submitted to the Ministry of Health.

3. For details, please refer to the relevant official notice (in Spanish) at http://www.cofepris.gob.mx/Documents/LoMasReciente/10102013L.pdf.

ENQUIRIES

4. For enquiries concerning the content of this circular, please contact the undersigned at 2398 5682.

Yours faithfully,

(Ms Linda Ng)

for Director-General of Trade and Industry