In Case You Missed It from Acorn Regulatory: CEP’s, Orphan Drugs, Packaging & More
Our expert team has written hundreds of insightful articles on all aspects of regulatory affairs, pharmacovigilance, clinical trials, compliance and more. Here, we are highlighting some of the best writing from our recent archive in #ICYMI. In this latest edition of In Case You Missed It from Acorn Regulatory we are featuring articles on issues as diverse as smart packaging, the common missteps on CEP’s and much more.
1. Orphan Drugs: 10 Facts You Need To Know
Much has been written about orphan drugs in recent times. These products, developed specifically to treat a rare disease, have become more common in the marketplace. At the time of writing (May 2018) there are almost 300 orphan drugs commercially available and more than 400 orphan designated drugs at clinical trial phase.
As the sector continues to grow there has been a tendency for facts about orphan drugs to get lost in the midst of issues concerning specific patients needs, pricing and availability. In this article we look at some facts about orphan designation that companies considering entering the sector should be aware of.
Read more here.
2. What Are The Steps To Consider In a Repeat Use Procedure?
In this article, we look at the issue of Repeat Use Procedure. We give an overview and consider some of the issues that need to be addressed during the process.
What Is A Repeat Use Procedure?
According to the CMDh the ‘Repeat Use Procedure’(RUP) is the use of the Mutual Recognition Procedure (MRP) after the completion of a first MRP or Decentralised Procedure (DCP) for the recognition of a marketing authorisation by other Member States (MS).
Read more here.
3. Virtual Wholesaling of Medicinal Products: 5 Things You Need To Know
In this article we look at the five things that you need to know when considering virtual wholesaling.
What is Virtual Wholesaling?
Simply put, virtual wholesaling is selling or buying medicinal product without any physical contact with that product. Thus a company engaged in virtual wholesaling are not holding medicinal products and do not need a storage site or warehousing facilities. Warehousing and storage requirements are either contracted to storage providers or managed by the supplier or the customer.
Read more here.
4. Eleven Commonly Deficient Issues When Applying For A Certificate of Suitability (CEP)
The Certificate of Suitability or CEP is a certificate issued by the European Directorate for the Quality of Medicines (EDQM) that certifies the compliance of a pharmaceutical substance or active pharmaceutical ingredient (API) with the requirements of the relevant monograph of the European Pharmacopeia and therefore the EU directives for medicines. A list of all CEPs granted is available on the EDQM website.
Read more here.
5. What Are The Benefits Of Smart Packaging In The Pharma Sector?
Much has been written about the benefits of smart packaging for the pharmaceutical sector. The introduction of smart packaging technologies is regarded as another step in safeguarding the security of medicinal products and devices. Below, we look at smart packaging and consider the benefits that it might bring to our sector.
Read more here.
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