Arızalı Ürünlerin Geri Çekilmesine İlişkin DRAP Kılavuzları: Prosedür | Pakistan

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The Pakistan İlaç Düzenleme Kurumu Ülkenin sağlık ürünleri düzenleyici kurumu (DRAP), ülke pazarına sürülen sağlık ürünlerine ilişkin takip edilecek geri çağırma prosedürlerine yönelik bir kılavuz belge yayınladı.

Belge, geçerli düzenleyici gerekliliklere ilişkin bir genel bakışın yanı sıra tıbbi cihaz üreticileri ve ilgili diğer taraflarca bunlara uygunluğun sağlanması için dikkate alınması gereken ek açıklamalar ve öneriler sunmaktadır.

Yetkili makam ayrıca, söz konusu değişikliklerin temel mevzuattaki ilgili değişiklikleri yansıtması için makul olarak gerekli olması halinde, belgede ve burada sunulan tavsiyelerde değişiklik yapma hakkını saklı tutar. 

In particular, the document provides a comprehensive overview of a recall procedure to be followed by the parties responsible for medical devices once a defective product is identified. 

Recall Procedure Overview

First of all, the authority emphasizes that recall procedures are critical mechanisms designed to safeguard patients and consumers from the potential dangers associated with defective therapeutic goods.
These goods may be harmful under regular usage conditions, fail to meet their marketing authorization specifications, lack therapeutic efficacy, or are not being produced in line with the Good Manufacturing Practice standards.

The primary responsibility for initiating a complete recall, whether voluntary or mandated by regulations, lies with the product’s licensee as the main party responsible for the product allowed for marketing and use in the country.

This action reflects the legal obligations of manufacturers, wholesalers, and retailers to protect public health from products posing health risks or defects.

Stages of a Product Recall

The document further outlines the critical stages of recalls. A product recall is typically comprised of the five key stages:

1. Receipt of Information on Defective Product: The process begins when a licensee receives complaints or reports concerning a product’s quality, safety, or efficacy, prompting them to inform the DRAP about the recall specifics, including the nature of the problem, product details, and initial actions taken.
   
2. Submission of Information for Recall Assessment: The licensee must submit detailed information about the recall for DRAP’s evaluation, including the problem’s nature, product specifics, and a risk assessment along with proposed actions.
   
3. Recall Assessment: DRAP and the Action Group on Risk Assessment and Recall of SF Products assess the provided information to finalize the recall’s classification, level, and strategy.
   
4. Recall Communication: Effective communication strategies are implemented to ensure that defective products are removed from the market.
   
5. Monitoring and Evaluation of Recall: The recall’s effectiveness is monitored, and follow-up actions are recommended to prevent future incidents.

Action Group on Risk Assessment and Recall

According to the document, the Action Group, comprising representatives from DRAP, provincial health departments, and quality control laboratories, is crucial in receiving and evaluating reports of defective therapeutic goods.

They determine the recall’s classification and level, devise a strategy for effective recall, and monitor the implementation of necessary actions by licensees.

Classification and Levels of Recall

By the applicable regulatory requirements, recalls are classified into three main categories based on the health risks they pose:

• Sınıf I: Represents a significant risk of severe health consequences.
  
• Sınıf II: May cause temporary or medically reversible adverse health consequences but are not life-threatening.
  
• Sınıf III: Unlikely to cause harm but are recalled for other reasons, such as non-compliance with marketing authorizations.

The level of recall is determined by the extent of the product’s distribution, with specific protocols for the consumer/user level, distributor/wholesale level, and further details on the depth of recall necessary.

Recall Strategy Implementation

The recall strategy will be developed based on gathered information and in consultation with the Action Group.

It should cover the recall’s scope, notification methods, communication of the recall message, customer instructions, and logistics for returning the product.
The strategy also considers the impact of the recall on market supply and consumer health.

Sonuç

In summary, by the virtue of this guidance, the authority emphasizes the importance of swift action and thorough communication to mitigate risks associated with defective therapeutic goods. By following these guidelines and the underlying legislation they are based on, regulatory bodies, manufacturers, and distributors can effectively manage recalls, ensuring patient and consumer safety while maintaining trust in the healthcare system.

Kaynak

https://www.dra.gov.pk/wp-content/uploads/2024/02/Draft-Recall-Guidelines-Edition-2-V1-.pdf

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Kayıt Masası tıbbi cihaz ve ilaç şirketlerine dünya çapında 120'den fazla pazar için düzenleyici bilgiler sağlayan bütünsel bir Düzenleyici Bilgi Yönetim Sistemidir. Merkezi bir platform aracılığıyla küresel uygulamaları hazırlamanıza ve yayınlamanıza, standartları yönetmenize, değişiklik değerlendirmeleri yürütmenize ve mevzuat değişiklikleriyle ilgili gerçek zamanlı uyarılar almanıza yardımcı olabilir. Müşterilerimiz ayrıca kritik sorularla ilgili doğrulama almak için dünya çapında 4000'den fazla uyumluluk uzmanından oluşan ağımıza erişebilir. Küresel genişleme hiç bu kadar basit olmamıştı.