What are the agents reached by the National Traceability System?
The "National Drug Traceability" must be implemented by all natural or legal persons involved in the marketing chain, distribution and dispensing of medicinal preparations (laboratories, distribution, logistics operators, drugstores, pharmacies, care facilities and laboratories processors immediate use nutritional solutions).-
What medical specialties should be drawn?
All those listed in Annex I of the No. ANMAT 3683/11 and No. ANMAT 1831/12, as well as any new medical specialty in the future is registered and has no similar domestic, whatever the active pharmaceutical ingredient (IFA).
From where should start traceability?
Traceability should start from the first link that is the finished product, sea this one imported the national. Usually, laboratory will holder. However, where product to enter directly from the office to the distributor, this will enable a laboratory structure and secondary packaging, where placement fee will support the unique code required by the regulations. Each laboratory that sends products to this space must assign a GLN, being responsible for the affixing and use of the codes, without prejudice to the outsourcing of the activity carried out. Otherwise, laboratory must always start starter.-
What is the first event to report?
It is not necessary to inform the laboratory internal movements owner, but since there is a physical movement of products, either between plants themselves or a third party laboratory (p. ej. distributor). Where products are shipped to a third party in quarantine, must specify this by a specific event scheduled in the system. If the product is imported or produced locally within the laboratory plant in nature registrant quarantine, and physical movements recorded until this state is lifted, inform the first event will be the "product distribution to a back link."- While not mandatory, the laboratory can report quarantining and lifting it within your deposit.
How should encode laboratories registration certificate holders of medicinal preparations made by the National Traceability System?
Laboratories should place holders, in the packaging of each of the retail units, a support device with the capacity to store a code univocal, as recommended standard GS1, containing the following information:
• GTIN or commercial code Product • Serial number up to twenty (20) • The alphanumeric characters corresponding application identifiers: (01) GTIN for y (21) for series.
If the initiator is the laboratory traceability certificates holder Record Medical Specialties listed in Annex I of the Provisions No. 3683/2011 and 1831/2012 Does the drugstore should add a new label for traceability?
Drugstores can only identify medical specialties not reached by the above standards when those laboratories were acquired, distribution or logistics operators, in such a case must proceed according to the provisions of Article 3 of the No. ANMAT 3683/2011, namely:
• GLN or physical location code of the establishment. • Serial number seven (7) alphanumeric. • The corresponding application identifiers: (414) for GLN and (21) for series.
The drug companies can not implement mechanisms and / or traceability systems that do not conform to the requirements of the above standards, as well as logo placement, name or other identification of the establishment in question in support traceability used, except for the indication of the company holding.
What are the deadlines for the implementation of the Regulation No. 3683/2011?
From laboratory to from drugstore to drugstore and pharmacy, the deadline for implementation expires 15 December 2011. Con closes after them, medications must be received not achieved in Annex I of the Regulation No. 3683/2011 pose in unequivocal identification of GTIN (Global Trade Item Number) + show.- To validate the system, from the laboratory head until dispensed to the patient, the deadline for implementation expires 15 June 2012.-
Do laboratories holders may use any data carrier or recommended any particular?
Achieved agents should place, in the packaging of each of the retail units, a stand or device capable of storing a univocal code as recommended standard GS1. In all cases, in addition to the carrier, code should incorporate visible, in human readable alphanumeric characters, so as to permit verification by patients. However, establishments that incorporate physical media or devices with ability to uniquely identify medicinal specialties, must ensure that it can not be removed without leaving an obvious mark on the packaging, and makes it possible that the latter has been violated.
What codes should be used by pharmacies, health care facilities, intravenous mixtures laboratories and government deposits, instead of GLN?
Such agents may also use granted by GS1 GLN or GLN derivative thereof sub, or must use a Physical Location Code Establishment (CUFE) to interact with the system. In case you have not yet this code, must apply through trazabilidad@anmat.gov.ar or to the help desk (0800-333-89633). The granting of CuFe no charge is made, only having to prove the respective sanitary certification that qualifies the facility to join the System.
Which data will be entered into the system when performing ANMAT dispensed to the patient?
In the case of providing patients, the pharmacy provider or health care facility must provide the delivery was made to a patient, with the data for social work or prepaid and membership number. Personal data are omitted for reasons of privacy and confidentiality, while retaining such information separately for if necessary contact the patient for the purpose of preventing any risk to their health and / or life, or to realize the market recovery units that will be delivered.
What are the logistical movements must inform agents achieved?
• Code damaged / destroyed.- • Sending and receiving of products in return character.- • Distribution of product to a link and receiving the product back from an earlier link.- • Sending and receiving deposits products among themselves.- • Sending and receiving quarantined items.- • Product intended for medical displays.- • Product intended for clinical trial.- • Product intended for export.- • Product stolen / lost.- • Reentry stock product.- • dispensing the product to the patient.- • Lifting of quarantine.-
Product events recalled prohibited and will be informed by ANMAT and expired products will be informed automatically by the system, so that the agent according to health regulations applicable jurisdiction.-
What data should inform each agent to the Database?
Laboratories and natural or legal persons involved in the distribution chain and dispensing of medicinal preparations reached by the National Traceability System shall, order to market, distribute and dispense the same, bar none, unique code associated to the following distribution:
• Lot number.- • Due Date.- • recipient code (GLN u child, accordingly).
In the case of providing patients, the pharmacy provider or health care facility must provide the delivery was made to a patient, RNOS code and membership number if health coverage. The same data will be properly decoupled and stored, ensuring the necessary confidentiality.-
• Domicile recipient (effective home delivery).- • Delivery date.- • Invoice and associated refer to the distribution or dispensing operation.-
Are social works and prepaid medicine companies are part of the System?
NO, these institutions are not health facilities. Just be sure that the companies that contract comply with traceability requirements, arises under the Resolution No. 594/11 Superintendency of Health Services.-
In the case of drugs included in the National Traceability System, health care facilities that fractionate those laboratories medical specialties and nutritional solutions developers immediate use, Can they access the database of more than one patient ANMAT destination? For these two agents is expected to enter the entirety of the patients targeted database ANMAT.-
How the system should inform medical samples?
The laboratory, logistics operator or distributor may report that certain series are intended for medical samples, data reporting medical propaganda agent who receives. Remember that only those samples should be drawn with the same medical presentation unit sales.-
In clinical studies should be drawn? Comparators? Comparators draw is mandatory included in research protocols that have IFA'S involved in the above provisions.
Do you need to trace the products for export? Laboratory is up to the owner. In case of tracing it, is created the event to inform.
The traceability system replaces die?? The information contained in supporting traceability, Built based on the provisions ANMAT No. 3683/2011 o Nº 1831/12, replace the information currently contained in the die of medicinal preparations reached, substituting in its use.
Should put some kind of seal or security label to medical specialties?
Medicinal specialties ALL PRESCRIPTION must have a security system package, which shall be inviolable and prevent opening them up to the time of use and have security measures to prevent replication, so as to ensure that the secondary package containing the product actually produced by the holder.
