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COLLEGIATE DIRECTORATE RESOLUTION - RDC NO. 430,

OF OCTOBER 8, 2020
Provides for the Good
Distribution, Storage, and
Transportation Practices for
Medicines.

The Collegiate Board of Directors of the National Health Surveillance

Agency, in the use of the attributions conferred on it by art. 15, III and IV, coupled
with art. 7, III and IV of Law No. 9.782, of January 26, 1999, and art. 53, VI, §§ 1
and 3 of the Internal Regulations approved by the Collegiate Board Resolution -
RDC n° 255, of December 10, 2018, resolves to adopt the following Collegiate
Board Resolution, as deliberated in a meeting held on October 7, 2020, and I, the
Substitute CEO, determine its publication.
CHAPTER I
PRELIMINARY PROVISIONS
Section I
Goal
Art. 1 This Resolution has the objective of establishing the
requirements for Good Distribution and Storage Practices and Good Drug
Transportation Practices.
Section II
Scope
Art. 2 This Resolution applies to companies that perform the activities
of distribution, storage, or transportation of medicines and, as applicable, to the
storage and transportation of bulk products.
Sole paragraph. This Resolution does not apply to the activities of
distribution, storage and transportation of raw materials, medical gases or labels
and packages.
Section III
Definitions
Art. 3 For the effect of this Resolution, the following definitions are
adopted:
I - storage: safe keeping, handling, and conservation of medicines;
II - storage in transit: a set of procedures, of temporary nature, related
to the transit of cargo, involving the activities of receipt, temporary custody,
conservation, and safety of medicines;
III - Good Storage Practices (GSP): set of actions that ensure the
quality of a drug through adequate control during the storage process, as well as
provide tools to protect the storage system against counterfeit, reproved, illegally
imported, stolen, faulty, and/or adulterated drugs;
IV - Good Distribution and Storage Practices (GDSP): set of actions
that ensure the quality of a drug through the appropriate control during the
distribution and storage process, as well as provide tools to protect the
distribution system against counterfeit, reproved, illegally imported, stolen,
defective, and/or adulterated drugs;
V - Good Transportation Practices (GTP): a set of actions that ensure
the quality of a drug through adequate control during transportation and storage
in transit, as well as provide tools to protect the transportation system against
stolen, damaged, and/or adulterated drugs;
VI - cold chain or cold network: process encompassed by storage,
conservation, handling, distribution, and transportation activities for temperature-
sensitive products;
VII - contamination: the unwanted introduction of impurities of a
chemical or microbiological nature, or of foreign matter, into a bulk or finished
product during the storage or transportation stages;
VIII - container: an environment used for storage or transportation of
products, which can be refrigerated and temperature controlled;
IX - outsourcing contract: a document mutually agreed and controlled
between the parties, establishing the attributions and responsibilities of the
contracting and contracted companies;
X - expiration date: the deadline for the use of a drug defined by the
manufacturer, based on its respective stability tests, provided the established
storage and transportation conditions are maintained;
XI - distribution: a set of activities related to the movement of cargo
that includes the supply, storage, and shipping of drugs, excluding the direct
supply to the public;
XII - distributor or wholesale: comprises the commerce of drugs, in
any quantities, carried out between legal entities or to professionals for the
exercise of their activities;
XIII - shipping: set of procedures related to the shipment for the
transportation of medicines;
XIV - batch: a defined quantity of product processed in one or more
processes, whose essential characteristic is homogeneity;
XV - cargo manifest: document that contains a list of the goods that
make up the cargo of the ship, aircraft, and other transport vehicles;
XVI - thermolabile drug: drug with a maximum temperature
specification equal to or lower than 8°C;
XVII - batch number: defined combination of numbers and/or letters
that uniquely identifies a batch on its labels, batch documentation, corresponding
certificates of analysis, among others;
 XVIII - logistic operator (OL): a company with an Operating
Authorization (AFE) and a Special Authorization (AE), when applicable, able to
provide transportation and/or storage services;
XIX - standard operating procedure (SOP): a written, authorized
procedure that provides instructions for performing operations that are not
necessarily specific to a given product or material, but are of a general nature (for
example, operation, maintenance, and cleaning of equipment, qualification,
cleaning of facilities, and environmental control, sampling, and inspection);
XX - returned product: finished product, shipped and commercialized,
returned to the registration holder or distributor;
XXI - bulk product: any product that has gone through all the
production stages, not including the packaging process; sterile products in their
primary packaging are considered bulk products;
XXII - qualification: set of actions carried out to certify and document
that any facilities, systems, and equipment are properly installed and/or function
correctly and lead to the expected results;
XXIII - thermal qualification: documented verification that the
equipment or controlled temperature area ensures thermal homogeneity inside it;
XXIV - quarantine: temporary retention of finished products, physically
isolated or by other means that prevent their use, while awaiting a decision on
their release, rejection, or reprocessing;
XXV - receiving: set of activities related to the arrival, checking, and
internalization in stock of medicines;
XXVI - recall: action that aims at the immediate and effective
withdrawal from the market of a certain batch(es) of medicine, with sufficient
evidence or proof of quality deviation, that may represent a risk to health, or by
occasion of cancellation of the registration, related to the safety and effectiveness
of the product, to be implemented by the holder of the registration and its
distributors;
XXVII - consignment or delivery: quantity of a given drug supplied in
response to a purchase order, a single consignment may include one or more
volumes and materials belonging to more than one batch;
XXVIII - active control system: those with active temperature and/or
humidity control, capable of self-adjusting to external temperature variations,
such as refrigerated containers for air and sea transportation and refrigerated
trucks;
XXIX - passive control system: those without active control of
temperature and/or humidity, such as thermally insulated containers made of
polystyrene or polyurethane, with cooling material. They are not capable of
adjusting themselves to external temperature variations, their capacity being
determined by means of studies and temperature and humidity forecasts for the
route in question;
XXX - transporter: a company that transports medicines from the
sender to a certain recipient, and may additionally perform storage in transit;
 XXXI - return: return to the supplier of the drugs fiscally incorporated
to the client's stock and that, in this manner, entered the client's custody chain.
These drugs, when returned to the origin, are done so with a fiscal or
corresponding document, distinct from the shipping document.
CHAPTER II
GENERAL PROVISIONS
Art. 4 All parties involved in production, storage, distribution, and
transportation must take responsibility for the quality and safety of the drug
products.
Sole Paragraph. Shared responsibility encompasses recall actions,
regardless of whether this is motivated by the sanitary authority, the registration
holder, the distributor, or the logistics operator.
Art. 5 The principles of GSP, GDSP, and GTP must also be observed
in reverse logistics, when the drugs are being returned or collected from the
market.
Art. 6 - The distribution companies must supply drugs only to
companies licensed and authorized by the competent sanitary authority for the
activities of distribution or dispensing of drugs.
Sole paragraph. The supply of radiopharmaceuticals must be carried
out by institutions licensed by the Health Authority, the National Nuclear Energy
Commission (NNEC), and other competent authorities.
Art. 7 The acquisition of drugs from distributing companies other than
those that hold the registration is allowed as long as the traceability of the load
through the National System of Drug Control - NSDC is guaranteed.
Sole paragraph. When NSDC is not applicable, traceability must be
guaranteed through documentary proof by the supplying distributor that the origin
is licit and authentic.
Art. 8th The establishments that perform the activities of distribution,
storage, or transport of medicines must have a quality management system
capable of documenting, verifying, and ensuring the specific requirements for
each process that has an impact on the quality of the products.
CHAPTER III
DISTRIBUTION, STORAGE AND TRANSPORTATION
Section I
Organization and Administration
Art. 9 The company's organizational structure must be described in
an organizational chart.
Single paragraph. The responsibilities of all personnel must be
indicated in the job descriptions.
Section II
 Staff
Art. 10: The company must have an appropriate number of employees
with adequate qualifications, ensuring that the responsibilities assigned
individually are not so extensive as to present risks to the quality of the product.
Art. 11: Requirements related to health, hygiene and clothing of the
personnel must be established, according to the activities to be performed.
Art. 12: The systematic training of employees whose functions have
an impact on the Quality Management System must be described.
1 - The employees referred to in the caput of this article must receive
initial and periodic training, according to the complexity of the activity and
compatible with the training action taken.
2 The records that allow the identification of the trainee, the date of
execution and the workload, as well as the strategy used, the subjects covered,
and the evaluation of effectiveness, must be kept.
§3 Training requirements relevant to each job position, as expressed
by policies, programs, procedures, and forms, must be defined.
Art. 13: Smoking, eating, drinking (with the exception of drinking
water, which must be available in a specific sector), chewing, keeping plants,
food, personal medicament, personal objects, or any other object strange to the
sector, is forbidden in the storage, storage in transit, receiving, and dispatch
areas.
Section III
Quality Management System
Art. 14: The Quality Management System must cover all aspects that
influence the quality of the drugs or services provided.
Art. 15: The processes that impact the quality of the medicines or
services provided must be mapped.
Single paragraph. The processes identified in the mapping must be
preceded and governed by standard operating procedures, with the proper
generation of records.
Art. 16: The actions of the Quality Management System are the
responsibility of the entire company and must be exercised by all its members.
Art. 17 - The divergences in relation to the requirements expressed
by the Quality Management System must be interpreted and treated as non-
conformities.
Art. 18 The area responsible for the Quality Management System
must have hierarchical autonomy and the necessary resources for the exercise
of the following functions:
I - ensure the implementation and maintenance of a quality system;
II - to coordinate document management;
 III - elaborate, review, and formally approve the standard operating
procedures;
IV - adopt and maintain a self-inspection program;
V - adopt and maintain initial and periodic training programs;
VI - to supervise the collection activities, including collection
simulations;
VII - to receive and investigate complaints;
VIII - to manage the returned products;
IX - implement a system for change control and management;
X - verify and ensure the legal requirements for sanitary licenses and
operating authorizations of the members of the drug distribution chain when
exercising the distribution activity;
XI - managing the qualification and calibration of equipment and
instruments;
XII - to register, investigate, and adopt corrective and preventive
actions for the identified non-conformities;
XIII - manage waste;
XIV - guarantee the integrity and traceability of the drugs and of the
data relative to commercial transactions;
XV - implement a plague management program with safe agents,
regularized at the competent agencies and that do not offer contamination risk to
stored products;
XVI - perform the communications foreseen to the sanitary organs
according to the models established and disclosed by them and communicate to
the commercial partners and competent police authorities when there is theft and
identification of counterfeit or adulterated products; and
XVII - to ensure the appropriate destination for counterfeit products.
Subsection I
Documentation
Art. 19 - The management and control of quality documents must
have guidelines for the preparation, review, approval, distribution and control,
training, codification, safekeeping, and obsolescence of documents in physical or
electronic format.
Art. 20: The standard operating procedures must be followed and be
available at their respective workplaces.
Art. 21 - The standard operational procedures must be kept up to date
so that they correspond to routine practice.
Art. 22: Standard operating procedures must be understandable to
employees and must be unambiguous.
 Art. 23 Records, manual or electronic, must be readily retrievable, and
must be stored using security measures against any unauthorized modification,
damage, deterioration, or loss.
1. The correction of recorded data should be done by justifying the
need for alteration, preserving the possibility of reading the data originally
recorded.
2. Backups must be kept for records generated or stored in electronic
format.
Art. 24: The standard operational procedures as well as the manual
or electronic records must be kept for at least 5 (five) years after obsolescence.
Single paragraph. Access to these documents must be restricted to
the people delegated by the Quality Management System.
Subsection II
Complaints
Art. 25: A customer service to receive complaints must be established
and disclosed to the clients.
Complaints related to the quality, authenticity, legality, or integrity of
the drug products or those related to adverse events must be registered and
investigated.
1 The responsibility for the investigation extends in proportion to the
participation of each entity in the chain in causing the deviation.
2. The investigation must classify the complaints in founded or
unfounded, confirming or discarding the related non-conformities.
It is up to the investigation to define the root cause of the problem,
evaluate the impacts on customers, and suggest, if necessary, to the
manufacturer or registration holder, the recall.
§4º The investigation should consider the possibility that other
batches of the drug have been affected by the same root cause.
Corrective actions should be defined, implemented, and monitored for
situations where the recurrence of non-compliance poses a risk to the patient.
Art. 27 Complaints related to quality deviations must be registered
separately from those related to distribution, storage, or transportation activities.
Single paragraph. Complaints related to quality deviations must be
passed on to the manufacturer or registration holder for investigation, and the
results of this investigation must be added to the initial registration.
Subsection III
Recall
Art. 28 - The recall must comply with the provisions of this Resolution,
without prejudice to the provisions given in the Collegiate Directorate Resolution
- RDC 55 of March 17, 2005 and its updates.
 Art. 29 - The registration holder is responsible for coordinating the
collection.
Single paragraph. The participation in the recall by the distributor,
storage or logistics operator extends proportionally to the contribution of each
one in the distribution map and to the root cause of the collection.
Art. 30: The distribution maps must be readily recoverable for a period
of time consistent with the validity of the distributed drugs.
1. The registration data relative to the companies on the distribution
map must be up to date and contain the minimum information necessary for
postal, telephone, and electronic mail contact.
§2º A reconciliation simulation between the units distributed and
located at the customers must be performed once a year for the worst case of
the distribution network, in order to test the effectiveness of the recall and correct
possible failures.
Art. 31 - The holder of the registration must be consulted previously
about the recall when it is done by another company in the distribution chain.
At the end of the recall, an evaluation of the effectiveness of the
communications issued and the degree of recovery of the distributed units must
be registered in a report.
Art. 33. All customers and the competent health authorities of all
countries to which a certain drug product has been distributed must be notified
immediately when the need to recall a certain batch is detected.
Single paragraph. The person responsible for the recall must keep
records of the notifications and proof of receipt.
Subsection IV
Returns
Art. 34 Before a returned drug product is returned to marketable stock,
at least the following factors must be recorded and weighed by the quality
management system:
I - the reason for the return;
II - the storage and transport conditions employed by the buyer;
III - the integrity of the original secondary packaging; and
IV - the expiration date.
Art. 35: Failure to ensure that the returned drug remains within its
quality standards shall result in rejection of the reinstatement.
Art. 36. The drugs that are objects of theft, robbery or other
misappropriation, even if they have been recovered, must be rejected.
Paragraph 1 - The drugs described in the caput that have the chain of
custody interrupted by theft, robbery or other misappropriation and that do not
present damage or violation of the shipping box and safety devices present at the
moment of the event and that can be concluded as adequate from the point of
view of quality, safety and effectiveness by means of a risk analysis performed
under the responsibility of the distributor, can be reintegrated to the commercial
stock.
Paragraph 2 The provision in the previous paragraph does not apply
to thermo-labelled drugs.
Subsection V
Self-Inspections
Art. 37 - The processes with impact on Quality must be auto inspected
according to the frequency established and justified by the company.
Art. 38 - Self-inspections must be conducted by professional(s) not
hierarchically linked to the process or to the inspected department.
Sole Paragraph. The professionals referred to in the caput must be
specifically trained for the self-inspectionf activity.
Art. 39 - Self-inspections must be compiled in reports with the
following minimum information:
I - identification of the inspector team;
II - period;
III - non-conformities identified;
IV - corrective and preventive actions listed and their respective
completion and implementation deadlines;
V - actions to follow up the adoption and monitor the effectiveness of
corrective and preventive actions; and
VI - evaluation and agreement of the heads of each affected
department and the highest hierarchical position in the company.
Subsection VI
Qualifications and Validations
Art. 40. Equipment and computerized systems must be qualified and
validated before use or after any change considered significant.
Sole paragraph. The risk analysis can be used as a tool for dispensing
with the need for qualification and validation of equipment that has no significant
contribution to quality.
Art. 41 A preventive maintenance program must exist for the
equipment with impact on quality.
Section IV
Storage Facilities
Art. 42 - The exercise of the activity of medicine storage requires, at
least
 I - area for receiving and shipping drugs separated from each other;
II - general storage area for medicines;
III - area or place for storing returned medicaments;
IV - area or place for storing reproved, expired, recalled, suspected of
being falsified, or counterfeit drugs;
V - area or place for storing drugs subject to the special control
regime, when applicable;
VI - area or place for storing drugs in quarantine, when applicable;
VII - storage area for medicaments with radionuclides, when
applicable;
VIII - storage area for cleaning materials;
IX - administration area; and
X - canteen or refectory area, when existing, and changing rooms,
toilets, and washbasins, without direct communication with the storage areas.
1 - The alternation of schedules, the delimitation of the common area,
color coding, or other procedures to reduce the risk of exchanges should be
adopted when the separation required in item I is not possible.
2. Any storage areas should have restricted access, however, the
areas or locations indicated by items III, IV, V, and VII should be separated from
the others and should have differentiated access control.
3 The substitution of physical quarantine described in item VI by a
qualified computerized system is possible.
The mentioned areas must protect the products from bad weather and
animals.
Art. 43 - The storage areas must be provided with the necessary
equipment and instruments for controlling and monitoring the required
temperature and humidity.
§1º Monitoring should be carried out by instruments positioned
according to the thermal qualification study of the area.
The reading of the instruments, if taken intermittently, must
correspond to the periods of greatest criticality.
3 The monitoring must be recorded, and the records must be kept, for
at least two years after their generation.
The instruments must be calibrated before their first use and at
intervals defined and justified by the instrument's performance and measurement
sensitivity.
Art. 44 - The installations must have a dimension compatible with the
volume of operations performed.
 Art. 45: The installations must have smooth surfaces, without cracks
and without dust release, to facilitate cleaning and avoid contaminants.
Art. 46 - The facilities must be cleaned with the help of cleaning
equipment and agents approved for this purpose.
Single paragraph. The cleaning operations referred to in the caput
must be registered.
Art. 47: The installations must be provided with adequate lighting to
enable all operations to be carried out accurately and safely.
Art. 48 - The areas destined for maintenance, when existing, must be
separated from the storage areas.
Sole paragraph. Repairs, maintenance, and calibrations performed
must not compromise the quality of the drugs.
Section V
Storage
Art. 49 - Defective drugs must be removed from usable stocks and
stored separately as reprobates.
Art. 50 - The storage conditions of the drug products must follow the
specifications of the holder of the registration.
Art. 51 - Medicaments must not be placed directly on the floor or
against the walls, must keep a minimum distance from the roof, and must not be
in places with direct incidence of sunlight.
Art. 52 - The pallets must be made of material that allows cleaning
and is not a source of contamination, such as treated wood, aluminum, or plastic
materials.
Art. 53 The storage must obey a logical addressing that avoids
exchanges and provides the unequivocal location of the stored quantities.
Art. 54 - The storage must obey the load configuration established for
the drug product.
Sole paragraph. The provisions also apply during transportation,
storage in transport or when stored by logistic operators.
Art. 55 - Periodic inventories of stock must be carried out.
Single paragraph. Inventory discrepancies must be recorded and
investigated to ensure that no mixing, incorrect invoicing, or theft has occurred.
Section VI
Receiving and Shipping
Art. 56 Each receiving operation must verify and record:
I - the applicable transportation and storage conditions, including
special temperature, humidity, or light exposure requirements;
 II - the lot numbers, expiration date, and quantities received against
the orders placed and invoices received; and
III - the integrity of the cargo.
Art. 57 Cargo that does not comply with the receiving requirements
must be returned upon receipt or be quarantined while awaiting its disposal by
quality assurance.
Art. 58 - The fractioning of drugs from their transport packaging must
not violate the secondary packaging.
Single paragraph. The fractioning operation must be carried out in
accordance with specific separation orders for the quantity to be fractionated and
must have a specific record with a conference at the end.
Art. 59 Electronic files related to shipping must include at least the
following information:
I - date of dispatch or receipt;
II - corporate name, address, and CNPJ of the transporter;
III - full name and identification document of the driver;
IV - the recipient's corporate name, address, and CNPJ;
V - description of the drugs, including name and presentation;
VI - quantity, batch numbers, and expiration date;
VII - applicable transportation and storage conditions, including
identification of the vehicle responsible for transportation and serial number of the
instrument used for monitoring environmental conditions, when applicable;
VIII - unique number to allow the identification of the delivery order;
and
IX - invoice number.
Art. 60 - The invoices issued must contain the lot numbers and origin
data of the traded drugs.
Art. 61 - The order of the load in the vehicles or containers must be
done in such a way as to avoid damage to the drugs.
Single paragraph. Vehicles and containers must be loaded carefully
and systematically and, when applicable, follow the sequence first in, last out.
Art. 62 Delivery schedules and routes must be established according
to local needs and conditions.
Section VII
Transport and Storage in Transit
Art. 63 - The obligations of those contracting drug transportation
services are
I - qualify the transporters;
 II - provide orientation and technical assistance in case of accidents
involving the drugs under transportation, together with the Technical Manager of
the hired company.
Art. 64: The companies that transport medicines have the following
obligations
I - have the transported cargo manifest with the prediction of
unloading on board the transporting vehicle;
II - monitor the transport conditions related to the specifications of
temperature, packaging, storage, and humidity of the drug using calibrated
instruments;
III - apply the passive or active temperature and humidity control
systems that are necessary to maintain the conditions required by the sanitary
registry or other applicable specifications;
IV - provide the contracting party with all data relative to conservation
conditions during transportation, as well as during storage in transit;
V - provide restricted access to medicines; and
VI - to receive and deliver drugs only to duly authorized and licensed
companies for the related activities.
1 The control foreseen in item III can be eliminated when using
qualified transportation conditions for the route.
2. The obligation to monitor temperature and humidity as provided for
in item II can be exempted when the maximum transportation time is proven in
the records to be less than 8 (eight) hours, when it is carried out to the final point
of dispensing the drug, and when thermal packages are used that have the
appropriate qualification for the time and conditions of transportation.
Art. 65 The transportation systems used must have mechanisms that
provide evidence of unauthorized access.
Sole Paragraph. Carriers or logistic operators, when in the carrier
activity, are forbidden to violate the cargo carried.
The guidelines concerning storage facilities, warehousing, and
receiving and dispatching foreseen in this norm also apply to storage in transit.
Art. 67. Vehicles, equipment and containers shall not expose the drug
products to conditions that can affect their stability and the integrity of their
packaging or generate contaminations of any nature.
Art. 68 Vehicles and containers must be adequately maintained and
cleaned.
Art. 69 - The collected or returned drugs, as well as those suspected
of being falsified, must be identified in a clear and safe manner and, whenever
possible, mechanisms must be used to allow the segregation during
transportation.
 Art. 70 Shared transportation with other product categories is only
possible when the risks have been analyzed, mitigated, and concluded as
acceptable.
Art. 71 - In case of accident, theft or robbery of radiopharmaceuticals,
NNEC must be informed.
Section VIII
Outsourcing
Art. 72 Outsourcing of the activities regulated in this norm must be
preceded by approval of the contract by the quality management system.
1 - The approval referred to in the caput of this article results from the
qualification of the contracted service provider.
The qualification of the supplier should be based on the verification of
specific requirements and should be registered.
Maintenance of the provider's status as qualified should be
periodically re-evaluated using indicators established for this purpose.
The contract between the contractor and the contracted party must
establish the responsibilities of each party.
Sole Paragraph. The contract referred to in the caput of this article
must foresee that subcontracts depend on prior assessment and approval by the
original contractor.
Art. 74 - The contracting party must supply the contracted party with
all the necessary information to correctly carry out the contracted operations, in
accordance with the drug's registration and any other legal requirements.
Art. 75 The contractor and the contracted party must be able to meet
the legal and regulatory requirements applicable to them.
Art. 76 - The contractor must have adequate facilities and qualified
personnel, in order to satisfactorily perform the service requested by the
contracting party.
Section IX
Thermolabile Medicines
The exposure to ambient temperature during the reception and
expedition of thermolabile drugs should be minimized, including, if necessary, the
adoption of refrigerated areas near the reception and expedition spaces.
Sole Paragraph. The total exposure time of the thermolabile drugs to
room temperature, during the operations referred to in the caput of this article,
must be registered.
Art. 78 - The storage of thermolabile drugs must be done according
to the recommendations of the registration holder in a thermally qualified medium.
 Art. 79 - The equipment involved in the storage of thermolabile drugs
must have, besides the primary source of electric energy, an alternative source
capable of immediately supplying energy in case of failure of the primary source.
Art. 80 - Contingency plans must be prepared to protect the
thermolabile drugs in case of power failure or failure of the storage equipment.
Art. 81 Emergency cooling alternatives, such as liquid nitrogen or dry
ice, may be acceptable, as long as the preservation conditions established by the
registration holder are maintained.
Single paragraph. When adopting these alternatives, precautions
must be taken so that temperature excursions below the specified minimum do
not occur.
Art. 82 - If it is impossible to adopt a barrier system for the storage
sites of thermolabile drugs, the movement of stock must be planned in advance
in order to reduce temperature variations as much as possible.
Art. 83 - The transportation of thermolabile drugs must be done in a
thermally qualified medium.
Art. 84 Monitoring and control of temperature during storage and
transportation must be performed.
Art. 85 The arrangement and assembly of loads for transportation
must be oriented by the registry holder to distributors, transporters, and logistic
operators and must be based on the cold chain qualification studies.
Sole paragraph. The arrangement of the loads must avoid the direct
exposure of the drugs to the cooling agents used for temperature conservation.
CHAPTER IV
FINAL PROVISIONS
Art. 86 - The non-compliance with the provisions contained in this
Resolution constitutes a sanitary infraction, under the terms of Law nº 6.437, of
20 August 1977, without prejudice to the applicable civil, administrative and
criminal responsibilities.
Art. 87: The following are hereby revoked
I - the Collegiate Board of Directors Resolution - RDC No. 304, of
September 17, 2019, published in the Official Gazette of the Union of September
18, 2019; and
II - the Resolution of the Collegiate Board of Directors - RDC No. 360,
of March 27, 2020, published in the Official Gazette of the Union of March 31,
2020.
Art. 88: The following are restored
I - Ordinance No. 802, of October 8, 1998, published in the Federal
Official Gazette of October 9, 1998; and
II - the Collegiate Directory Resolution - RDC nº 320, of November 22,
2002, published in the Federal Official Gazette of November 25, 2002.
 §1º The rights of third parties are safeguarded, in the period between
March 16, 2020 and the date immediately prior to the date of publication of this
Resolution, provided that they have acted in good faith and provided that their
activities have been practiced in accordance with the Collegiate Board of
Directors Resolution - RDC No. 304, of September 17, 2019.
The normative acts listed in items I and II of this article will be
automatically revoked as of the date this Resolution goes into effect.
Art. 89 The period of one (1) year as of the date this Resolution comes
into effect is established for the application of the set of actions that will be
necessary for the implementation of what is required in items II and III of art. 64.
Paragraph 1 - During the period mentioned in the caption of this
article, the companies that make up the distribution chain must generate
temperature and humidity mapping studies that will subsidize the active or
passive control measures that will be applied to the transportation systems.
Paragraph 2 - During the period provided for in the caput of this article,
all the data produced do not generate, due to the transience given, additional
obligations to the companies as regards the control of temperature and humidity
conditions and, therefore, are not considered, even when out of their acceptance
range, infractions to the requirements of this norm, as long as the quality of the
drugs is preserved.
3 The transitory nature provided for in the caput of this article also
applies to storage in transit, as this activity is intrinsic and inseparable from
transportation.
Art. 90 This Resolution comes into effect on March 16, 2021.
Sole Paragraph. Exceptions to the provisions in the caput of this
article are articles 7 and 87 and clauses I and II and § 1 of art. 88, which are in
force immediately on the date this Resolution is published.