Labeling Compliance

Drug labeling and package leaflets play an important role for both patients and healthcare professionals in the safe and efficient use of the medication. Hence, the approval of the labeling content, Patient Information Leaflet (PIL), and Summary of Product Characteristics (SPC) are integral components of the marketing authorization process.

Health Authorities in MEA issued Guidance for Presenting the Labeling Information, SPC and PIL” for drafting, to enable the applicants use & to ensure standardization of the product information. We in PharmaMEA are taking care to let those complying with the standard in each country in the MEA; at the same time complying with claims that matching your business targets.

Some of the key tips:

Labeling and Patient Information Leaflet (PIL):

Data displayed in the label should follow the given template, regardless of the actual labeling sequence, location, and potential duplication on the individual sides/flaps.

A separate text should be completed for outer and inner packaging labeling.

Applicants should submit an Arabic version, for certain products, of these specifications.

So as to ensure the implementation of these guidelines, marketing authorization holders will have to acquire sound Regulatory knowledge and realign with these new requirements of product information guidelines and templates to avoid non-compliance. 

Consulting a specialized Regulatory labeling services provider will enable companies to effectively contain costs and focus on core business operations.

Contact our specialists to tailor a service plan.

Regulatory Affairs