1 – I have products registered in the name of my distributor or even in the name of a
company that hosts registers. Is it possible to make another registration of these same
products, i.e., having the same product registered twice by different companies
(registration holders)?
BRISA ADVISORS: Yes, it is possible to have the same product registered by more than
one registration holder at ANVISA. But also, it is possible to transfer ownership of class
III and IV products when the current registration holder agrees with this procedure.
2 – In which cases can I request the transfer of ownership of registers?
BRISA ADVISORS: In corporate and commercial operations between companies that
carry out activities subject to sanitary control – ANVISA, which implies the change of
ownership of product registration, since the conditions and technical-sanitary
characteristics of companies, products and clinical trials are kept.
3 – Which are the definitions adopted by RDC No. 102/2016?
BRISA ADVISORS:
I – technical and health characteristics: regular conditions of the product, company, or
clinical trial at ANVISA, immediately before the corporate or commercial operation;
II spin-off: corporate operation in which a legal entity transfers parts of its property to
one or more legal entities established for this purpose, or already existent, extinguishing
the demerged company if all its assets are transferred, or dividing the capital if the
transfer is partial;
III – succeeded company: legal entity that transfers to the successor company the rights
and obligations on the product object of registration transfer, the establishment, or the
responsibility for clinical testing as a result of corporate or commercial operations;
IV – successor company: legal entity that now has the rights and obligations on the
product object of registration transfer, the establishment, or the responsibility for
clinical testing as a result of corporate or commercial operations;
V – merger: corporate operation in which two or more legal entities are merged to create
a third one, succeeding them in all rights and obligations;
VI – incorporation: corporate operation in which one or more legal entities are absorbed
by another one, succeeding them in all rights and obligations;
VII – commercial operation: operation between companies resulting in the sale of assets
or group of assets, without the occurrence of any corporate transaction between the
companies involved;
VIII – corporate transaction: corporate action involving the merger, spin-off or
incorporation under Law no. 10,406, of January 10th, 2002, and, in a subsidiary manner,
Law no. 6,404, of December 15th, 1976;
IX – Mercosur representative: company located in the Receiving State Party [Estado
Parte Receptor (EPR) in Portuguese], which is contracted to represent a registration
holder in the Producing State Party [Estado Parte Produtor (EPP) in Portuguese] and
assumes the legal and technical responsibility in the EPR;
X – global transfer of responsibility for clinical testing: modification characterized by the
change of the applicant of clinical trial dossiers, notification of clinical testing, dossiers
of clinical development of drugs (DDCM), dossiers of clinical investigation of medical
devices (DICD), expanded access programs, compassionate use programs and supply of
post-study drug, in cases of corporate or commercial operations, without any change of
technical and health characteristics contained in the Specific Special Communiqué
[Comunicado Especial EspecĂfico (CEE) in Portuguese], Document for the Import of
Product under Investigation or Special Communiqué), object of change;
XI – transfer of registration holder: modification characterized by the change of the
registration holder of products subject to health surveillance, in case of corporate or
commercial operations, without any change of technical and health characteristics in
the registration of product object of transfer.
4 – In cases of commercial or corporate operations carried out abroad, does this RDC
also apply?
BRISA ADVISORS: Only in cases where these operations carried out abroad imply the
need to update data at ANVISA by the registration holder in Brazil, such as updating the
CBPF or in case of alteration in the registers of existing products to communicate with
the new manufacturer.
5 – Can the Certificate of Good Manufacturing Practices (CBPF) and the Company’s
Operating Permit (AFE) be transferred along with the registration of the product?
BRISA ADVISORS: In fact, already published BPF certificates can have their updated
registration data for the new applicant, provided that the previously examined
technical-health characteristics, whenever the corporate or commercial operation of
registrations of already deferred products. The validity of the certificate does not
change, it will remain the same as the initial order made by the succeeded company.
For initial requests of CBPF that are still awaiting or with analysis not yet completed, it
will not be possible to update the registration data. The succeeded company must
promote the addition of the petition to update the documentation, with a view to
instructing and continuing the analysis of the petition in progress.
The AFE may be updated through a petition for amendment, cancellation, or concession,
whenever there is a corporate transaction that will result in a new person legal entity,
or when there is already a legal entity not regularized with the surveillance health,
regularization will always be through an initial grant request for AFE.
It is important to point out that the Certificate of Good Manufacturing Practices are
granted for each establishment, by production line. When the succeeded company’s
original certificate must be maintained, the successor company must request on its
behalf a new certificate for the line involved. This situation may lead to a new sanitary
inspection.
6 – Which are the deadlines that must be watched?
BRISA ADVISORS:
a) 180 days: For requests for transfer of ownership and cancellation of registration of
health products, which must be concurrently filed with ANVISA, respectively by the
successor and succeeded company, the period is up to 180 (one hundred and eighty)
days from the date of filing of the corporate act registered with the board of trade or of
the celebration of the contractual instrument of the commercial operation, or, in the
case of a representative Mercosur, will be counted from the date on which the
interruption of the contractual relationship between the parties contained in the
Declaration (Annex I of the RDC 102/2016) is formalized.
b) 180 days: Companies will have a maximum of one-hundred and eighty (180) days to
sell out the remaining stock of finished products after the entry into force of Resolutions
of cancellation and transfer of registration.
c) 90 days: Resolutions of cancellation and transfer of ownership registration of products
subject to health surveillance addressed in this resolution shall come into force ninety
(90) days after its publication and until this date the effects of registering the product
object of the transfer remain valid.
7 – About new protocols. referring to post-registration, how should it be made?
BRISA ADVISORS: ANVISA’s suggestion is to only make new protocols regarding changes
post-registration after the entry into force of the registration ownership transfer
resolution, i.e. on the day following the 90-day deadline for the publication of the
resolution. This is due to the fact that responsible areas of ANVISA will be migrating the
files previously selected in the transfer request by the succeeded company and that it
will be awaiting analysis or with analysis not yet completed. The goal is to avoid mistakes
in these analyses.
8 – And in the case of revalidation of register during the period of vacatio legis (90-
days deadline for the entry into force of the transfer ownership)?
BRISA ADVISORS: The deadline for revalidation of registration cannot be neglected
under penalty of loss of registration. Registration revalidations must be requested
between 12 to 6 months before the registration expiration. It must be done by the
succeeded company – if it is done prior to the application for registration ownership
transfer or in the vacatio legis period (90 days), and must be informed the responsible
management about the interest in analyzing the petition. Or by the successor company,
after the validity of the cancellation resolution and ownership transfer.
9 – Which products are subject to registration ownership transfer?
BRISA ADVISORS: Only products subject to registration, class III and IV, may be the
object of registration ownership transfer. Products subject to notification, class I e II,
must be the object of new notification.
10 – What documents must be included in the petition for the registration ownership
transfer?
I – application form duly completed and signed;
II – payment proof of the Health Surveillance Inspection Fee (TFVS in Portuguese)
through the corresponding Brazilian Federal Tax Collection Form (GRU), or a fee
exemption voucher;
III – declaration of the corporate or commercial operation performed, as provided in
Annex I; and;
IV – copy of the Operating Permit or Health Permit issued by the competent body,
properly updated after the corporate or commercial operation;
11 – Does the registration number change when transferring ownership?
BRISA ADVISORS: The registration ownership transfer carried out simultaneously in the
Official Gazette of the Union, with the new registration number and the cancellation of
the old number, keeping unchanged the characteristics of the product and the
expiration date of the registration transfer object.
12 – Registration requests that are awaiting analysis, or with analysis not yet
completed, may be subject to registration ownership transfer?
BRISA ADVISORS: Registration requests under analysis cannot be subject to registration
ownership transfer. In these cases, the succeeded company must promote the addition
of the petition to updating the documentation, with a view to instruction and the
continuation of the analysis of the ongoing petition already on behalf of the successor
company.
The same goes for changes to the registry in progress, through the completion of the
declaration of interest of the successor company.
13 – Can I adapt the texts of instructions for use and labels along with the registration
ownership transfer?
BRISA ADVISORS: No. When transferring ownership, no technical-health characteristic
of the product can be changed. Only on the first day after the entry into force of the new
registration, that is, on the day following the 90 days of publication of the resolution, it
is possible to require adequacy in the texts of instructions for use, package inserts and
labels resulting from the registration ownership transfer.
Technical Note 63/2019 clarifies that CBPF is not considered a company asset certificate
applicant and for this reason is not subject to registration ownership transfer and
commercial operation. The correct act to request from ANVISA is to update the data
registration documents of the BPF Certificate already published, and as long as they
involve products already registered.
14 – The successor company, result of a corporate operation that resulted in a new
legal entity, or for an existing legal entity, but not regularized with ANVISA, can carry
out imports even before obtaining the AFE itself?
BRISA ADVISORS: Imports by the successor company may be carried out based on the
AFE of the succeeded company, until ANVISA’s decision on the regularization of the
company, as long as the protocol deadlines established by the RDC 102/3016 are
obeyed. The importing company must present a certified copy of the declaration of the
corporate or commercial operation carried out for the health authority of the place of
clearance.
15 – Who is responsible for the product and any stock remainder of finished goods
after transferring ownership?
BRISA ADVISORS: The successor company is responsible for operational activities such
as commercialization, depletion of stock and importation of products, from the date of
protocol of the petition for registration ownership transfer, and this control is improved
for the entry into force of the registration ownership transfer itself. Until transfer of
ownership of product registrations occurs, the importations carried out by the successor
company must be accompanied by a statement from the succeeded company,signatory
of the product regularization petition with ANVISA, authorizing each import.
We emphasize that the succeeded company has joint responsibility before the health
surveillance entities and organs for acts performed prior to the operation corporate or
commercial.
16 – Is it possible to trade the remaining stocks of finished products objects of the
registration ownership transfer?
BRISA ADVISORS: Yes, the remaining stock of the finished products subject to the
registration ownership transfer be regularly imported or commercialized by the new
holder of the registration, provided that it was produced before the entry into force of
the Resolutions of cancellation and the registration ownership transfer.
17 – What is the deadline for depleting this remaining stock?
BRISA ADVISORS: Companies will have a maximum period of 180 (one hundred and
eighty) days after entering into force of the cancellation and registration ownership
transfer Resolutions to deplete remaining inventory of finished products. This deadline
comprises the steps of importing and marketing the products.
Attention: it will not be allowed the use and depletion of any remaining stock with
outdated wording or labeling information to new batches produced after the entry into
force of the cancellation and the registration ownership transfer.
18 – Should I keep the corporate act or commercial operation of the transfer of assets?
BRISA ADVISORS: ANVISA may, at any time, request a copy of the filing certificate of the
registered corporate act, in case of corporate transaction, or the contractual instrument
transfer of assets or a set of assets, in the case of commercial operation.
Find out more about BPO in RA!
*Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br
