Our Health Authority, INVIMA, issued Resolution 2014026516 dated August 19th, 2014, which came into effect on July 26th, 2014updating the tariffs for sanitary registration applications and processes of its competence.
As a consequence of the update, some official fees have increased and new official fees were established in connection with sanitary regulations regarding certificates, permits and authorizations for the operation of establishments and the commercialization of products.
In order to facilitate transition, by means of circular 106-761-14 the Health Authority authorized applicants to use the receipts for deposits made prior to August 26th, or to request reimbursement in the events where the new tariff is lower than the old tariff. The deadline for these procedures is October 31st, 2014.
The main changes introduced by Resolution 2014026516 refer to the following aspects:
-The modification of the code description of visits to certify technical production capacity of establishments, resulting in two new codes:
1.Certificate to manufacturers in: Production capacity of visual health medical devices, and sanitary conditions of medical devices and in vitro diagnostic reagents.
2.Certificate to importers in: Capacity to conditioning and storage of in vitro diagnostic reagents; capacity to conditioning and storage of medical devices.
-The addition of new codes derived from the code of certifications and authorizations corresponding to authorizations of importations of non-available vital medicines for a single patient, several patients, clinical emergency and national production of medicines.
-The addition of new codes derived from the code of certifications and authorizations regarding authorizations of importations of samples without commercial value of alcoholic beverages and food.
-The addition of new codes derived from the code of certifications and authorizations about authorizations of importations as international donations of medicines and medical devices.
-New tariffs corresponding to certification of Good Laboratory Practices (GLP), including the following concepts:1.Certification visits or renewal of the GLP certification to establishments that provide Medicines Quality Control service, located in Colombia or in foreign countries.
2.Certification visits or renewal of the GLP certification to establishments or laboratories that belong to the manufacturing laboratory and conduct Medicine Quality Control analysis, located in Colombia or in foreign countries.
3.Visits for extension of the certification to establishments certified with GLP for the authorization of new analytical techniques, new analysis areas, new analysis equipment, critical changes to the analysis methodologies, specific analysis to the stability study and other processes that have not been authorized in the previous certifications visits, located in Colombia or in foreign countries.
4.Certification visits or renewal of the Good Manufacturing Practices (GMP) of medicines, along with certification visit or renewal of the GLP certification of medicines which operate at the same facilities and with the same name and address of the manufacturing laboratory, located in Colombia or in foreign countries.
-The update of codes which identify the fees applicable to sanitary registration or renewal of sanitary registration of medicines, and modification of sanitary registration in case of changes that affect the efficacy, safety or pharmacological aspects of the medicine.