Today's blog is about registering heparin at ANVISA in Brazil. A versatile and commonly used product, which has more than one classification with ANVISA, depending on how it is applied. Recent studies have proven the effectiveness of this anticoagulant even in combating Covid-19. Did you know? Check it all out here!
Before understanding exactly how to register heparin in Brazil, it is important to present some information.
Usually people refer to heparin as an anticoagulant medication, but the term “heparin” refers to the active pharmaceutical ingredient (IFA) that gives rise to the medication. This input is biological, that is, of animal origin, specifically from the intestines of pigs and cattle.
Heparin is widely used as a medicine, both in the prevention and in the treatment of thrombosis and embolisms (arterial and venous). It is a substance obtained mainly from the bovine and porcine intestinal mucosa, and can be applied to both humans and animals.
We can say that heparin is a versatile substance, because it has different classifications that depend on the way it is used. Thus, ANVISA classifies heparin as an input and also as a medicine, in addition to being also found in health products (diagnostic tubes).
When classified as a medicine, heparin can still have two categories: biological medicine or new medicine, both of which are applied by injection.
Thus, in order to register heparin at ANVISA, it is very important to know exactly the purpose it will have.
As a medicine, heparin is further divided into unfractionated (UFH) and low molecular weight (LMWH), the latter of which has shown better results and less side effects in the beings receiving the doses.
Full attention should be paid to the company's regulatory issues before considering the registration itself. For this, because we are facing medications and pharmaceutical inputs, that is, products with a high risk potential for health, it is necessary that, first of all, complete regularization of the company through obtaining the Operating License and the Company Operation Authorization (AFE), with the need for the Good Manufacturing Practices Certificate (CBPF), since heparin may have a risk classification. Those are the first steps.
After the perfect regularization of the company within its determined category, it is necessary to identify the risk classification of the product, which if greater than II, requires the Certificate of Good Manufacturing Practices (CBPF). Therefore, in the case of the anticoagulant in question, both as an active pharmaceutical ingredient and as a medication, CBPF is required.
So, finally, the time comes to think about registering heparin in Brazil, which happens by presenting a series of documents listed in the specific Resolutions of each category.
Extracting an average, usually in the case of registration of pharmaceutical input, the time is from 90 to 120 days, and in the case of drug registration, the average time is from 90 to 180 days. But it is very important to remember that it is not possible to set the exact time.
It is impossible to determine precisely how much it costs to register heparin in Brazil, because the required documentation and their respective values vary according to the company's activity and size.
Did you know that the anticoagulant drug heparin can reduce cell infection by Covid-19 by up to 70%? Some resonance techniques have observed that heparin, when bound to SARS-CoV-2 proteins, causes a change in these molecules. In this way, heparin acts by preventing the entry of the virus, “locking the lock”. The virus is not able to multiply if it does not enter the cell, being prevented from multiplying and proliferating the infection.
At Stone Okamont the bureaucracy is zero! Did you know that we can take care of the whole process for you to register heparin at Anvisa? We are specialized in regulatory intelligence to satisfy our customers. That's right! Leave your concerns to the care of those who really understand the subject.
Editor: Maria Júlia Carminati
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