Transport Operating Permit is obligatory for companies and shipping business.
Now you are about to know how it works the requirement of AFE in Anvisa for companies that perform the shipping of those products.
What is it – AFE? (Transport Operating Permit)?
AFE is an operation permit (document of AFE). It is a document that strengthen every information that the company is legally able to operate everything that the document is holding.
This document holds some of the company’s data and the permit number.
The code that refers to the company’s operating permit dispose according to the RDC num. 16/2014, with the exception of pharmacies and drugstores.
Do shipping companies need the AFE?
All shipping companies that deal with products such as: cosmethics, sanitizing, household cleaning, health products, correlated products, hygiene products, food and medicine, need a federal permit. Even shipping companies without the host service.
Shipping companies, buy their time, needs the AFE, but don’t need Anvisa registration. Those who must register their products in Anvisa are the manufacturers or importers.
If the distributor wants to be the owner of a product registration, he can expand his activity and become an importer or manufacturer.
- Product transportation;
- Regulated truck;
- Vehicle with temperature control.
If the shipping products contains substances to a special control, the shipping company needs to own not only the operating permit AFE but also the special permit (AE).
How do shipping companies get the AFE?
The AFE is obligatory for companies that performs hosting services, distribution, packing, expedition, exportation, extraction, manufacture, fractionation, importation, production, purification, repacking, synthesis, transformation, medicine shipping, pharmaceutical input for human use, cosmetics, personal hygiene products, perfumes, sanitizing and fill or filling of medical gases.
Licempre take care of every process for you to have the AFA in ANVISA, requiring the AFE concession through the Electronic Petitioning and Collection System and wait for the publication of deferral in the Federal Official Gazette, only to then request the Certificate of AFE.
After that is done the petition process which consists of the following steps:
- Registration – first step for companies that provide regulated products or services at Anvisa.
- Change of company size – companies that wish to have their size changed if they wish.
- Petitioning – petition request process.
- Fees – where the collection rates related to the chosen subject are generated.
- Protocol – after the payment is made, the interested party joins all the requested documentation and sent to Anvisa.
The AFE Certificate will only be obtained if the company authorization is valid.
Do drug shipping companies need AFE / AE?
Drug transportation companies include in the process where AFE is requested from ANVISA. For drugs containing substances subject to special control other than AFE the carrier must obtain the AE.
In this scenario it’s important to mention that drug distributors need a technical manager. See below.
Art. 15 – The pharmacy and drugstore shall, necessarily, have the assistance of a responsible technician, registered in the Regional Pharmacy Council, in accordance with the law.
Paragraph 1. The presence of the responsible technician shall be mandatory during the entire opening hours of the establishment.
What is AE (Special Company Authorization)?
AE is a Special Company Authorization that is requested from ANVISA, which allows the activities related to pharmaceutical ingredients, drugs and substances under special control.
In this case, proof of the specific technical and administrative requirements contained in DRC 16/2014 is required.
Companies that perform these activities but do not have AE are subject to interdiction or cancellation of license and fines under Law No. 6,437 / 1977.
Who doesn’t need AFE or AE?
According to ANVISA, AFE is not required for the following establishments or companies:
I – who carry out the retail trade of health products for lay use;
II – branches that perform exclusively administrative activities, without storage, provided that the head office has AFE;
III – that carry out the retail trade of cosmetics, personal hygiene products, perfumes and sanitizers;
IV – engaged exclusively in the manufacture, distribution, storage, packaging, exportation, fractionation, transportation or importation of raw materials, components and inputs not subject to special control, intended for the manufacture of health products, cosmetics, hygiene products personnel, perfumes and sanitizers;
V – that perform exclusively the installation, maintenance and technical assistance of health equipment.
According to Law No. 13.043 / 2014, the yearly renewal of the Operating Authorization (AFE) and the Special Authorization (AE) are no longer mandatory.
Licempre is a company specializing in regulatory affairs at ANVISA. If you have any questions, talk to our specialist.