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Trade and Industry Department The Government of the Hong Kong Special Administrative Region
Brand Hong Kong - Asia world city
MY COLOUR

Commercial Information Circulars

24-hour hotline : 23 922 922

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

Ref : EIC 426/2

2 October 2013

Dear Sirs,

Commercial Information Circular No. 796/2013

Mexico : New Good Manufacturing Practices for Medicaments

Mexico's Ministry of Health has recently issued new mandatory good manufacturing practices for medicaments with therapeutic, preventive or rehabilitating effects, NOM-059-SSA1-2013 .

DETAILS

2.The regulation includes requirements in areas such as documentation, quality management systems, personnel, facilities and equipment, validation and qualification, production systems, returns, release of finished products, quality controls, product recalls, subcontractors and final destination of residues. These technical requirements will enter into force on 18 January 2014, although provisions related to biologic and biotechnology products will apply from 16 September 2013.

3.For details, please refer to the relevant official notice (in Spanish) at http://www.dof.gob.mx/nota_detalle.php?codigo=5307536&fecha=22/07/2013.

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



Note: While every effort is made to ensure the accuracy of the above information, the Department cannot guarantee this to be so and will not be held liable for any reliance placed on the same.