Effective as of 1 October 2005, the Pharmacy Law passed by the National Assembly on 14 June 2005 addresses many important issues in the pharmaceutical industry, including state policy, the state body responsible for administration of the industry, quality control of pharmaceuticals, and pricing of pharmaceuticals.
In particular, the new Law on Pharmacy regulates: business in pharmaceuticals, registration and circulation of pharmaceuticals, use of pharmaceuticals, information about and advertising of pharmaceuticals, clinical testing, administration of addictive pharmaceuticals, psychotropic drugs, pre-substances used to manufacture pharmaceuticals and radioactive drugs, quality standards and verification testing of pharmaceuticals.
Under the new Law, business in pharmaceuticals is a conditional business. In addition to a certificate for business registration (in the case of local companies) or investment license (in the case of foreign invested enterprises), companies conducting business in pharmaceuticals must obtain a certificate of satisfaction of conditions for conducting business in pharmaceuticals (eligibility certificate).
There are six forms of business in pharmaceuticals, including: 1) manufacture, 2) import and export, 3) wholesale selling, 4) retail selling, 5) preservation services, and 6) services of testing pharmaceuticals. A company may only conduct the form(s) of business in pharmaceuticals which is/are stipulated in the eligibility certificate. Of note, current foreign investment laws generally do not allow foreign invested enterprises to engage in the forms of business (2), (3) and (4) above.
In order to obtain an eligibility certificate, companies must satisfy the following conditions:
(a) They must have material and technical facilities and personnel with the professional qualifications necessary for the particular form(s) of business in pharmaceuticals,
(b) The person managing professional pharmaceutical matters must have been issued with a pharmacy-practising certificate.
The Ministry of Health is responsible to issue eligibility certificates with respect to the forms of business (1), (5) and (6) above and to issue practising certificates for persons working in FIEs. Departments of Health are responsible to issue eligibility certificates with respect to the forms (2), (3) and (4) above and to issue practising certificates for persons working in other entities.
This article was written by Phillips Fox lawyers