Simplify your promotional materials approval process
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08 Apr Simplify your promotional materials approval process

Posted at 11:44h in Problem-Solution, Regulatory Affairs by

Have you ever struggled with the local adaptation and approval/notification of promo materials for medicinal products? If yes, then you know it could be challenging and you might be interested to see our successful experience with promotional materials in Bulgaria.

The legal provisions that contain guidelines for the approval of promotional materials for medical specialists in Bulgaria are stated in the Law on Medicinal Products in Human Medicine (Chapter Eleven: Promotion of medicinal products) and Ordinance No. 1 (January 25, 2012) of the MoH. These regulations outline the requirements for the promotion of medicinal products. However, there are multiple other sources to be considered: starting with the Good pharmacovigilance practices and going deep to the local guidance published by the Bulgarian Drug Agency (BDA), industry’s codes of self-regulation, general rules of consumer protection and fair competition, etc.

What constitutes promotion, according to the Bulgarian legislation?

Medicinal product promotion is any form of information, presentation, communication, or offer intended to encourage the prescription, sale, or use of the medicinal product. For each material falling into this above category, the Marketing Authorization Holder must notify the BDA accordingly, following specific guidelines. So, it is not only about leave-behind materials.

Look no further than PharmDedict.

At PharmDedict, we understand compliance but also, we acknowledge the importance of getting your promotional materials approved swiftly and efficiently. That’s why we specialize in providing comprehensive solutions to meet all your regulatory needs. With our expertise and dedication, the quick and successful approval of advertising materials is routine for us.

A few reasons to trust PharmDedict with your promotional materials approval process.

Expert Guidance

Our team of regulatory experts is well-acquainted with the requirements of BDA. We will ensure that your promotional material contains all the necessary details to meet the approval criteria.

Time Efficiency

We understand that time is of the essence when it comes to getting your advertising materials approved. With PharmDedict, you can trust that we will work diligently to expedite the approval process without compromising on quality.

Customized Solutions

We recognize that each promotional campaign is unique, and we tailor our services to meet your specific needs. Whether you require assistance with content review, submission preparation, or regulatory strategy, we’ve got you covered.

By partnering with PharmDedict, you can have peace of mind knowing that your promotional approval process is in expert hands. We will handle all the intricacies of the regulatory requirements, allowing you to focus on other aspects of your business. Contact us today to learn more about how we can assist you.