ZAMRA ZAMRAZAMRA guideline Version 2, December 2019
ZAMRA guideline Version 2, December 2019 is the official ZAMRA identifier for “Application for Renewal of Marketing Authorisation of Medicines Registered Before 2015”. ZAMRA guideline Version 2, December 2019 is the official identifier ZAMRA uses for this instrument.
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Application for Renewal of Marketing Authorisation of Medicines Registered Before 2015
The transitional renewal guideline for marketing authorisations issued before 2015, made under section 39 of the Medicines and Allied Substances Act and Statutory Instrument No. 79 of 2019. Its cover version history reads "Draft Zero December 2019 / Version 1 draft December 2019 / Version 2 / Date of implementation December 2019"; the copy states no ZAMRA document number. It sets the general, administrative and technical requirements for a renewal submission and carries the application forms and the key-product-information template as its annexes. ZAMRA states on its face that it will issue a separate guideline for products registered from 1 January 2015 onwards, so this document is scoped to the pre-2015 cohort and should be read as such. It is ingested as `form-instructions` because what it principally contains is the completion requirements for a prescribed form.
ZAMRA guideline Version 2, December 2019 is the official identifier ZAMRA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.