Pharmaceutical products. Natural medicines for human use. Sanitary registration requirements
On 3 February 2012, the Government of the Republic of Guatemala notified, in document G/TBT/N/GTM/77, draft Central American Technical Regulation (RTCA) No. 11.03.64:11: "Pharmaceutical products. Natural medicines for human use. Sanitary registration requirements".
The description of content stated that the purpose of the draft was to establish the conditions and requirements for the sanitary registration of natural medicines for human use intended for marketing. The Technical Regulation applies to natural medicines for human use that are manufactured or imported by natural or legal persons for marketing in the Central American region.
It does not apply to products containing as the constituent responsible for pharmacological activity active substances that are chemically synthesized or isolated from natural material, or to ophthalmic or parenteral pharmaceutical products.
The purpose of the present Addendum is to notify WTO Members that this Technical Regulation has been updated and that there will be a comment and observation period of 60 days as from the date of this notification.