MAA Post Approval Submissions, Activities, Drug, Pharmaceuticals

Freyr support MAA Post Approval Submissions of Generic Medicinal products for EU member states to maintain the Regulatory compliance as per HAs by filing Variations and helps in streamlining the changes in formulation & Post-approval activities.

After a marketing authorization application (MAA) is granted approval in European Union (EU), in view of commercialization of a product (minimize costs, time or other reasons), the manufacturer may consider making necessary changes. Such changes must be notified to the Health Authorities (HAs) by proposing a Post-approval change submission.

As per the guidance, any changes proposed to the registered content in MAA shall be informed to HAs by filing Variations. Based on the impact of changes on quality of the medicinal product, they are categorised as:

• Major Changes: Have substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product / drug substance as these factors may relate to the safety and / or effectiveness of the medicinal product.

• Moderate Changes: Have moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product/drug substance as these factors may relate to the safety and/or effectiveness of the medicinal product.

• Minor Changes: Have minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product/drug substance as these factors may relate to the safety or effectiveness of the medicinal product.

Know more at Freyr Page: MAA Post Approval Submissions