How can I register my drug in Pakistan?
i) An application for registration of a drug shall be made in Form 5 (for local manufacture), 5-A (for imported drugs), 5-D (for new molecule) or Form-E (for Patent Drugs) accompanied by fee in duplicate to the Registration Board addressed to its Secretary, and separate application shall be made for each drug.
How do I register a new drug?
Applications for Registration/ Import License of New Drugs shall be submitted to the Drugs Controller General (India), Central Drugs Standard Control Organization (CDSCO), FDA Bhawan, ITO, Kotla Road, Delhi-110002. Phone: 91-11-23236965 /23236975. Fax: 91-11-23236973, as per Drugs & Cosmetics Rules in India.
What is Form 6 DRAP Pakistan?
APPLICATION FORM FOR ENLISTMENT OR RENEWAL OF CLASS–A MEDICAL DEVICE OR ACCESSORY OR COMPONENT FOR IMPORT.
What is DRAP certificate?
It is also called as gap year affidavit. The reasons for taking a drop (gap certificate) can be anything such as: Personal reasons. Health reasons. To prepare for the entrance examinations.
What is drug registration certificate?
“Registration Certificate” means a certificate issued under Rule 27A by the licensing authority in Form 41 for registration of the premises and the drugs manufactured by the manufacturer meant for import into and use in India. Not only drug but the manufacturing site needs to be registered for import.
How do you know if a drug is registered?
To check the list of products registered with the DCA, visit the official website of the National Pharmaceutical Regulatory Agency, www.npra.gov.my. Click on the ‘Registered Product Search’ (Quest 3) and enter the details of the product to start the search.
What is drug registration process?
It has been defined as: “a system that subjects all pharmaceutical products (under the scope of the NRA) to pre-marketing evaluation, marketing authorization (registration), and post-marketing review to ensure that they conform to required standards of quality, safety and efficacy established by NRA” (4).
How do I get NOC from DRAP?
After completion of application, DRAP analyze the request for NOC issuance decision. If request is rejected, DRAP informs the applicant. 5. If request is approved, DRAP issues NOC for import by Hospital and Institutional use.
What is Drug Act 1976?
The Drugs Act, 1976 regulates the import, export, manufacture, storage, distribution and sale of drugs. It extends to the whole of Pakistan. The provisions of this Act, are in addition to, and not in derogation of, the Dangerous Drugs Act, 1930 (11 of 1930), and any other law for the time being in force in Pakistan.
What is drug certificate?
A drug License is permission from the controller of the drug to deal with the drugs. Whether for wholesale or retail business, this drug license is issued subject to certain conditions attached to premises and the competent person. We assist pharmacies and pharma companies in obtaining the drug license.
What is registered drug?
A registered drug is a drug that is approved by the Drug Control Authority (DCA) for sale/use in Malaysia. This drug has been evaluated and tested for its efficacy and safety. Every registered drug is given a registration number, which must be printed on its label or package.