Law Summary
Objectives
- To promulgate revised requirements for instituting PACs to registered pharmaceutical products, incorporating ASEAN Variation Guideline and country-specific requirements.
- To provide a clear application process for the submission of PACs.
Scope
- Applies to all manufacturers, traders, and distributors (including exporters, importers, and wholesalers) of pharmaceutical products covered by ACTD/ACTR.
- In absence of specific regulations, coverage extends to single and multi-component vitamin and mineral products, vaccines and biologics, traditional medicines, OTC preparations, household remedies, medical gases, and veterinary products.
Implementing Details
Eligibility
- Marketing Authorization Holders (MAHs) may apply for PAC if they have a valid License to Operate (LTO) and a valid Certificate of Product Registration (CPR).
- Expired CPR must be included in a regular renewal registration if PAC is applied at expiration.
Classification
- PACs are classified according to the ASEAN Variation Guideline and country-specific requirements:
- ASEAN Variation Guideline Classes:
- Major Variation (MaV)
- Minor Variation (MiV)
- Prior Approval (MiV-PA)
- Notification (MiV-N)
- Country-Specific Classes:
- Major Variation examples: Additional route of administration, change of manufacturing site (same subsidiary).
- Minor Variation prior approval examples: Change of capsule color, change of brand name, change of MAH, reclassification (e.g., OTC to prescription).
- Other PACs not covered by AVG also included.
- ASEAN Variation Guideline Classes:
Application Process
- Applications for PAC may be submitted any time within CPR validity.
- Late applications near CPR expiry must be incorporated into regular renewal registration.
- Submission must follow latest FDA issuance procedures.
Requirements
- Follow AVG latest revision details available on FDA website.
- For prior approval changes (MaV, MiV-PA), a Letter of Request must be included specifying the PAC type and affected products.
- For minor variation-notification, include notification form with application.
- Country-specific PACs have additional specified requirements.
- Other unforeseen PACs will have requirements determined by FDA on a case-by-case basis.
- Multiple PACs on a product can be submitted together; recurring document copies can be submitted once.
- FDA may request additional info to ensure continued safety, efficacy, and quality.
Approval
- FDA issues a Certificate or Clearance for each approved PAC.
Fees
- Fees are charged per product and per change, including a Legal Research Fund (LRF) fee.
- A fee matrix is attached detailing specific fees for different types of PACs.
- Certain PACs (e.g., major changes such as indication, manufacturing site) are charged fees equivalent to initial registration.
- Fees may be revised by FDA and formalized in regulations.
Transitory Provisions
- The revised PAC requirements and procedures only apply to new PAC applications after effectivity.
- Pending applications prior to this Circular's effect are not subject to its provisions.
Repealing and Separability Clauses
- Inconsistent provisions from previous circulars are repealed or revoked.
- Invalidity of any provision or application does not affect the remainder of the Circular.
Effectivity
- The Circular took effect on 01 April 2014.