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National Pharmaceutical Regulatory Agency Ministry of Health Malaysia Lot 36, Japan Prof. Drama UGU Aziz, 46200 Pedaling Jay, Selangor. Phone. No. 0378835400 Website : http://npra.gov.myGARIS ANDEAN

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How to fill out drug registration guidance document

01

Ensure you have all necessary information about the drug product, including its composition, manufacturing process, packaging and labelling.

02

Complete the required forms and provide accurate information about the drug product.

03

Submit the registration guidance document along with any supporting documents to the appropriate regulatory authority.

04

Pay any applicable fees and wait for the regulatory authority to review your application.

05

Respond to any requests for additional information or clarification from the regulatory authority in a timely manner.

06

Once the application is approved, follow any further instructions provided by the regulatory authority.

Who needs drug registration guidance document?

01

Pharmaceutical companies and manufacturers who wish to market and sell their drug products

02

Healthcare professionals who need to understand the regulatory requirements for prescribing and dispensing medications

03

Regulatory authorities who oversee the approval and monitoring of drug products

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What is drug registration guidance document?

The drug registration guidance document is a document that provides instructions and information on how to register a drug with the regulatory authorities.

Who is required to file drug registration guidance document?

Any company or individual looking to register a drug with regulatory authorities is required to file a drug registration guidance document.

How to fill out drug registration guidance document?

The drug registration guidance document can be filled out by following the instructions provided in the document, which may include details on the drug, manufacturing process, quality control, etc.

What is the purpose of drug registration guidance document?

The purpose of the drug registration guidance document is to ensure that all necessary information about the drug is provided to the regulatory authorities for evaluation and approval.

What information must be reported on drug registration guidance document?

The drug registration guidance document must include information such as details about the drug, its manufacturing process, quality control measures, clinical trials data, etc.

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