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marketing Setup GrowthLTO is an authorization issued by the FDA to an establishment to grant permission to undertake a trade or carry out a business activity, such as manufacturing, importation, exportation, sale, offering for sale, distribution, or transfer of products.
Initial LTO has a validity of 1 to 2 years, while renewal is valid for 5 years.
The LTO shall be renewed within 90 days before its expiration as per Administrative Order 2020-017.
you may send us a message or email us at [email protected] and one of our consultant will answer all your queries.
you may send us a message or email us at [email protected] and one of our consultant will answer all your queries.
Unless the LTO is revoked, validity of GMP Certificate shall be coterminous with the LTO validity, whereas the HACCP Certificate shall only be valid for one (1) year.
you may send us a message or email us at [email protected] and one of our consultant will answer all your queries.
All pharmaceutical products, medical device, cosmetics, Household, vapor products, processed food and food products including food additives, food supplements and bottled water manufactured and/or distributed (i.e. imported, exported and/or wholesale for local distribution), for trade and/or repacked are required to secure a Certificate of Product Registration before these are sold, offered for sale or use, distributed or supplied, among other marketing and promotional activities .
No. Any change from the initially approved application, except for changes equivalent to initial application, shall be filed as amendment (e.g. compliance to CPR remarks, and other post-approval changes as per FDA Circular No. 2020-033) prior to filing of renewal application.
