Commercial Information Circulars
24-hour hotline : 23 922 922
e-mail address : enquiry@tid.gov.hk
Ref : EIC 414/2
5 November 2015
Dear Sirs,
Commercial Information Circular No. 1054/2015
Chile: Sanitary Registration Requirements for Pharmaceutical Products Containing Macromolecule
The Chilean government issued Exempt Resolution No. 2603/2015 on 13 August 2015 to approve the sanitary registration requirements for pharmaceutical products containing macromolecule.
2. Registration number of all pharmaceutical products containing macromolecule shall be assigned with letter "M" followed by a series of number. The registrants shall submit a complete description of macromolecule, pre-clinical studies of toxicity, and phase III clinical studies of efficiency, security and immunogenicity for the registration. The holders of the registered pharmaceutical products containing macromolecule shall submit a risk management plan and regular safety reports. The holders are granted six months from 13 August 2015 to use up their past product labels and brochures to professionals and patients.3. For details, traders are advised to consult their importers in Chile and/or the above Chilean Resolution (in Spanish) at: http://www.leychile.cl/N?i=1080362&f=2015-08-13&p.
ENQUIRIES
4.For enquiries about the content of this circular, please contact Mr Lewis LAU at telephone number 2398 5405.
Yours faithfully,
(Ms Lydia CHAN)
for Director-General of Trade and Industry