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Regulation/Guidelines

CDSCO has made it mandatory for Ethics Committee to get registered so as to get authority to review and accord its approval to Clinical Trial protocol

Under rule 122 DD Registration of Ethics committee (EC) – No ethics committee shall review and accord its approval to a clinical trial protocol without prior registration of the committee

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Regulation/Guidelines

Notification for Cosmetic Registration in India

The provision regarding registration of import of cosmetics into country has been implemented from 31st March 2013. Now, it is mandatory to get the registration done as per the new rules. We, at CliniExperts have a team to assist you for the registration process.

Regulation/Guidelines

Clarification For Import Of Non-Notified Medical Devices

Non-Notified Medical Devices donot require Registration certificate and Import Licence for import into India

Regulation/Guidelines

Guidelines on Registration of Import of Cosmetics

Guidelines on Registration of Import of Cosmetics (AS ON 2.1.2013) A: PURPOSE: 1. The Government of India has issued a Gazette Notification G.S.R 426(E) dated 19 th May 2010 for amending the Drugs & Cosmetics Rules, 1945 providing for registration of import of cosmetics into the Country. 2. The above provision was to come into effect from the 1st April, 2011. But in view of the various possible difficulties apprehended by the stakeholders, its implementation has been deferred till the 31st March, 2013. 3. With a view to implementing the provisions of the aforesaid notification and facilitate the registration process for import of cosmetics, the following guidelines / clarifications, including generalrequirements for grant of Registration Certificate, are being provided hereunder: 4. These guidelines are not exhaustive and may be augmented / modified further through additional guidelines or amendments of these rules, if considered necessary.

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