TRACEABILITY IS THE MOST EFFICIENT TOOL TO CONTROL REAL TIME TRANSACTIONS OR THE LOT OF A PRODUCT, VERIFYING ITS ORIGIN AND RECORDING THE HISTORY OF ITS LOCATIONS AND MOVEMENTS ALONG THE DISTRIBUTION CHAIN.
Resolutions of the pharmaceutical, veterinary, agrochemical and chemical industries.
Traceability in the pharmaceutical industry
Resolutions and provisions that regulate traceability in Argentina for the pharmaceutical industry:
Las droguerías deben implementar el sistema de trazabilidad Si los laboratorios ya implementaron el sistema, el mismo se debe mantener en todas las operaciones posteriores. GLN: Global Location Number + N° de Serie.
Para ingresar un medicamento a la base de datos se debe proporcionar:
- fecha de la venta
- número de remito y factura
- GTIN seriado
- cantidad de unidades vendidas
- número de lote
- fecha de vencimiento
Laboratorios y personas que intervengan en la cadena deben contar con los elementos de hardware y software necesarios.
En el caso de entrega a pacientes se omiten los datos personales del mismo por razones de reserva y confidencialidad. Dicha información estará disponible en caso de riesgo de salud/vida del mismo.
Cada establecimiento involucrado en la cadena debe implementar el sistema de Trazabilidad.
Base de datos deberá ser validada por ANMAT o un tercero que el mismo ANMAT disponga.
- Los establecimientos que incorporen los soportes (códigos/etiquetas/etc), deberán garantizar que los mismos no puedan ser removidos sin dejar una marca evidente.
- Que no pueda leerse el código si intento ser removido de alguna forma.
Traceability in agrochemical and veterinary products
Resolution that regulates traceability in agrochemical and veterinary products
- N° Lote
- F. Elaboración
- F. Vencimiento
- N° Lote
- F. Vencimiento
- Además, los productos veterinarios deben llevar N° de serie.
Traceability in chemical precursors
Resolution that regulates traceability in chemical precursors:
» Resolution 900/12
Frequently Asked Questions about traceability
In order to do the training you must access here and register in the system. You can do the training with the user and password you were given when you registered and entering the trial data in the documentation available on the page.
2. The training is stuck (Web or Webservice (WS)), what shall I do?
The events that indicate `medication lots` must be done with the option massive send selected (below in the same data entry screen) and entering a serial number from and to. This number must be sequential, for example, from 01 to 20. For the Webservice training, you must use the option sendMedicamentosDHSerie, which enables to enter serial numbers in lots (from and to) in the steps where medication lots are sent. If you use the single send of medications the training will not continue.
3. Training and Production users, where can you get them?
In order to get your training user you must register in the website or access in the step 2.1. The final user (Production user) will be communicated by an operator when you finish the training, register in step 3.2 and send the required documentation in the step 3.3. Once you get the final user, you must load the Subglns and products, if appropriate, and then close the alignment and print the PDF. Once you have completed the previous steps, you must wait for the user qualification by ANMAT.
4. What shall I do when the system blocks my password or I cannot access with my data?
If your user has been blocked for unsuccessful access attempts or because you don’t remember the data given when you registered you can ask for a new password directly from the webpage, from the option “unblock account or generate new password”. You should previously check that you are accessing to the right webpage, whether it is Training (step 2.3) or Production (step 3.5). Remember that the user and the password can be different according to the phase you are in.
5. What should I do if my organization or a third party doesn’t have GLN to trade?
a) Your organization does not have GLN: If your organization is a Laboratory/drug distributor/logistics operator/distributor, you must get your GLN in the GS1company. If your organization is a medical facility/drugstore/state warehouse, you can get the GLN in the GS1 company or you can ask for it in the help desk (you will be asked your Worker`s Identification Number, Trade Name, address, etc.) b) A third party doesn’t have GLN: they must ask for the temporary GLN from the option “ask agent” from the SNT entering their user and password (see instructions here accessing “news”) or getting in contact with the help desk.
6. For which medications is traceability mandatorily? What happens with the others?
Traceability is compulsory for the medications included in the Appendix of the ANMAT Resolutions 3683/2011 and 1831/2012. The medications that are not included in the Appendix can also be traced and included in the system, even though it is not compulsory for them to be traced by the previous or subsequent agents.
7. The product was traced but I cannot report movements in the web or webservice
Most probably, you have made a change in the sensitive data of your agent. In this case, you should align the data and print the PDF again. Then you have to wait for ANMAT to authorize your user again.
8. Must I add the GTIN number in the sales invoice? Who should be billed?
The traceability system is not a commercial system. What has to be traced is the physical delivery of the goods, the movement of the medications that you send o receive. That’s why you must report the GLN of the agents the product goes through, regardless of who is billed.
9. My authorization number is long and I cannot enter it.
The established format for the authorization numbers is NNNN/YYYY, where YYYY is the year. If you have a longer code or a code with other letters you must shorten it to this format. For example 123-spss-2011 must be entered 0123/2011
10. Who can enter medications in the system?
Laboratories are the only ones that are authorized to enter medications. If you are not a laboratory and the medication you want to trace is not in the electronic list you must ask the help disk to add it.
11. There is a mistake in the electronic data catalog (agent or medication)
You must report such mistake and give the correct data to the help desk or to the email firstname.lastname@example.org. The mistake will be corrected after the data is validated and authorized by ANMAT.
12. User and password for the transport layer of the WS
If you want to trace products using the webservices you must take into consideration that the data for the transport layer are the following: User: testwservice/ password: testwservicepsw. The information is independent of its user and password of the system and it is the same for the Training and Production as well.
13. I followed all the steps and I was authorized by ANMAT but I cannot trade through the WS. I get the error “5. You are not authorized to do this operation”.
In order to trade with the webservice in a productive way you must previously follow the steps of the training via WS, additionally to the steps followed manually through the web. The information about the steps to follow is available when you enter the Training web or accessing the menu Agents/My scoring. In order to finish your training through WS, you must access with your training data (user and password) in the step 2.3.
Phytosanitary products: On the primary packaging.
Veterinary products: the number can be placed on the primary or secondary packaging, depending on the commercial presentation of the product. If the number is placed on the secondary packaging, measures must be taken in order to preserve its integrity until it is used (Art. 14 – RS Nº 369-2013).
2. Must the import products be identified even though they are entirely consumed in plant?
Yes. If the SENASA Resolution Nº 369-2013 includes them, they must be codified.
3. If a packaging identified with serial number is divided, how is it identified?
Veterinary products: the identification, by lot or series, must be placed in the main unit for sale. This must only be done by the authorities authorized to that end by the DPVyAA. Its later division is an illegal activity (Chapter IV section 1.1 – RS Nº 681-2002).
4. Must the half-finished products have a GTIN to identify them? What SENASA certificate must be used in order to declare it?
They do not need a GTIN. They are not traced.
5. Where are the goods identified? What is the deadline once the product gets to the deposit?
The goods can be identified from its origin or they can be identified when they get to the deposit. In this case, it must be done within 24 hours.
6. Is it necessary to send a new labeling to be authorized by SENASA?
No, it is not necessary.
7. If a product is produced exclusively to be export, must it be labeled?
All the products that have active ingredients included in the SNT (national traceability system) must have GTIN, including those exclusively for export. The processes of elaboration and exportation must be declared, independently of the labeling used (depending on the legislation of the target country).
8. How to encode vaccines that have SENASA stamps?
Veterinary products: Vaccines are not included by the SNT at this early stage.
9. Can you use inkjet or must it be laser because of the inviolability?
You can use labels or Inkjet, provided they meet the specifications mentioned by SENASA Resolution No. 369/13. The label must be placed on a flat area as readers cannot read in curved areas. If using InkJet you can verify its legibility in GS1, which performs these tests for free.
10. Can Datamatrix and Barcode coexist?
It is not a good practice for traceability to keep both codes, as it may cause confusion for the person receiving the goods. Anyway, it is not prohibited.
11. How do you identify and declare a product pack?
Phytosanitary Products: It is stated by the pack number (coding in the secondary packaging). The capacity of the container that is being traced is specified in each pack.
Veterinary products: It is traced the product inside the pack that is included by the regulation.
12. Outsourcers. Is it necessary to identify the raw materials?
For SENASA they are processors. Therefore, they should register, identify the raw materials (active ingredients), declare receipt of them and declare the formulation of products in the system.
13. What happens with the same product that comes imported from various countries? Is the same GTIN used within the domestic circuit?
The gtin is unique for a product formulated with one or more sources.
14. In the case of an active principle coming from different sources and having the same registration number for SENASA, will it have two different GTINs?
Phytosanitary products: Each active ingredient with its plant has its own registration number and each of them must be identified in GS1 with the corresponding GTIN.
Veterinary products: In the case of veterinary products, the GTIN is the same.
15. Can the traceability information be included in the product label?
Yes. As long as there is enough space after complying with the labeling regulation and the requirements of the article 11 of the Senasa resolution No 369/13 are met.
16. Is it compulsory to declare the internal fractionation?
No, it isn’t. It isn’t compulsory provided that such intermediate packaging is not to be marketed.
17. Must the self-consumption of a product be declared? How?
Yes, using the self-consumption event.
18. How does the end user declare?
The end user does not declare. The retailer will report to the system the worker`s identification number of the final user.
19. Who declares an import in the case of using an outsourced importer?
The importer (registered in SENASA) must be registered in the traceability system and declare what it entered.
20. What about misstatements?
Misinformed statements may be canceled at the moment the error is detected. It must be considered that the system registers that the operation was canceled and this functionality should not be abused.
21. Can we sell if the client is not registered?
If the receiver of goods is a distributor or trader that has a longer period of time to enter the system, the company can sell to him but it must report those sales later using the event: ´send to trader not registered in the system` giving the worker`s identification number of the client.
When these clients must compulsorily enter the system, it won´t be possible to report this event.
Anyway, it is recommended for the dealers to register in the system at this early stage (without making statements but getting their GLNs) since the process for them is very simple and totally free.
22. For confirmation of export sales, must the buyer (from another country) enter the Traceability System?
Sales to a recipient outside the national territory must be declared in the system by the selling company. These transactions must not be confirmed by the foreign recipient.
23. Must stock transfers between stores and own subsidiaries be reported?
It is not mandatory to report such movements but it can be done with the corresponding event handling. When shipping to another company, it is mandatory to inform. The consignments must also be reported. The regulation says that “all activities must be traced whether they are onerous or not”.
24. What about the time-lags between physical production and its report to the company’s internal system and the arrival of information to SENASA?
See Article 4 of the Resolution. The loading to the system must be daily.
25. What happens to stocks as from the date of implementation of the Resolution? How to declare if they are not identified?
Stocks must be declared in a note to the front desk of DPVyAA and DIRABIO having the character of a sworn statement, indicating amount of packaging, capacity, lot number and expiration date, before the Resolution comes into force.
This stock will not be loaded in the system and must not be labeled. However, the products that are produced from that raw material that has not been traced must be labeled and reported. The receipts for return of non-labeled products will not be reported to the system.
26. When does this implementation come into force?
According to the Resolution 369/13, the importers, synthesizers, formulators and fractionators of phytosanitary products as well as the importers and formulators of veterinary products must join the Traceability System on 02/16/2014 (180 days since the Resolution Nº 369/2013 came into force).
For more information, see Resolution Nº369/2013- Art.8, Art.20
27. Is there an extension in order to implement the requirements?
There is no extension.
28. When must the distributors associate to GS1 Argentina and register in the traceability system?
Those encoding products of Annex I have 180 days (maturity: February 16th, 2014) to join the system. Those that are only dealers must join the Traceability System on 08/08/2014 (360 days since the Resolution N0 369/2013 came into force).
For more information, see Resolution Nº369/2013- Art.8, Art.20.
Anyway, it is recommended to register in GS1 as soon as possible since the process for them is very brief and totally free.
29. Must distributors have the GLN within 180 days?
It is not compulsory, but it is advisable.
30. What is geolocation?
It is to set the geographic location of all plants /deposits of the company.
31. Is there a list of growth promoters that are affected in this first stage?
The non-hormonal growth promoters are those approved veterinary products for that indication. The classification is established by DPVyAA in paragraph 2 of the Mercosur enrollment application and it is shown after getting the Certificate of use and sale.
32. In the case of the producers with certificate transfers, how are the statements made?
The company that markets a certificate extension must encode its extension. It holds a traceable product certificate.
Active ingredient (Phytosanitary products):
The companies that grant product transfers must ask GS1the corresponding GTIN. The companies that are given the transfers must ask for the GS1 to the company that grants them the transfer and encode the product with the lot number, expiration date and manufacture date.
33. SENASA System. Company register. How to register in order to perform many activities? Are there many different registrations? Can I register many activities in the same registration?
The system provides a menu to select all the activities for which the company is registered to SENASA. If any problem should arise, check with GS1.
Clarification: It must be taken into consideration when registering the company and its activities that they must not be different from those declared on DIRABIO and DPVyAA.
34. Special cases. Must the companies that only register the products but are not engaged in other system activities register?
Yes, they must register. Registrants must register their products, whether they do other activities in the system or not.
35. Transport. What happens if I invoice a product and do not receive it? How is it solved in the system?
You must not report reception of a product until you receive it in the deposit. If case of reporting the reception by mistake, you must cancel that reception transaction.
36. Confidentiality of the information sent. Must I sign a specific document?
All SENASA, PAMI y GS1 staff has signed confidentiality agreements.
Operators can only access their data and cannot see information of others.
37. Tolerance on losses. Is there an accepted deviation percentage?
To declare losses you must use the corresponding event. Shrinkages between 3% and 5% will be accepted. Anyway particular cases will be evaluated.
38. Relocation of products. What happens with target changes? How is the physical identification handled? For example, in the case of a product that you choose to export, must it change the GTIN? How to proceed in the system and in the labeling?
It must be labeled correctly according to what the system requires. Additionally, it may contain other label. The export to the corresponding country is declared in the system.
39. How to include expiration changes in the products that have useful life extension?
Phytosanitary products: refund of the product must be done before expiration for re-processing as long as it is authorized by DIRABIO.
40. In the case of reprocessed products, what is meant by manufacture date? The original date or the reprocessing date?
The traceability process is started again as a new product.
41. Can I try to report fictitious movements?
Yes, you can. For that purpose it is the training environment, which is a completely parallel environment that does not interfere with the definite environment.
Traceability: List of events
Event Action on stock Description
Trade buy Addition All the purchases or operations
Against payment performed with
Substances and/or products
Trade sale subtraction All the sales or operations
Against payment performed with
Substances and/or products
Trade sale to subtraction All sales performed
Final user complying with
the resolution 1137/11
Use of substances and/or products to produce other
Pure substances or products,
Subtracting stock of pure substances or products
Destruction subtraction Send for final disposition of
Substances and products
Negative balance subtraction Difference in weighting with
less quantity of substance or product
Positive balance addition Difference in weighting with
more quantity of substance or
Delivery of Subtraction Delivery of product processed
Product with an outside
Delivery for Subtraction remission of pure substance
Outside processing to process a product outside
Delivery by Not applied Transportation of substance or
Transportation product by a third-party not
Taking part in the event
Delivery for storage Subtraction Remission of substance or
Product for storage
Delivery for refund Subtraction Refund of substance or product
For different reasons
Delivery for Subtraction Remission of product or
Donation substance in any way as
Export Subtraction Overseas sale of substance or
Production Addition Manufacture/production of pure
substances or products, adding
stock of pure substances or
Import Addition Overseas purchase of substance
Reduction Subtraction Loss of substance or product for
Opening stock Addition Initial loading of substances or
Receipt Addition Receipt of product with an
Of product outside processing
With an outside
Storage Addition Receipt of substance or product
Receipt for Addition Receipt of pure substance for
Outside outside processing of a product
Receipt for Addition Receipt of substance or
refund Product for different reasons
Receipt for Addition Receipt of product or substance
Donation in any way as donation
Theft Subtraction Loss of product or substance
For misappropriation with or
Internal use Subtraction Use of substance or product for
Final consumption. Do not use for manufacture of product or
2. How often must operators load in the system the information about their movements? What is “real time”?
The frequency is decided by the operator. He can load the movements/events daily, weekly or monthly within the trimester and even 10 working days after the due date.
He must specify the loading date in each movement/event.
Example: If the operator performed movements/events every day in the trimester he can load each one of the movements/events until the last deadline.
“Real time” means that the day by day events are loaded in the system.
3. Must I get only one CUFE as real address (for example, plant and laboratory in the same address)?
Yes. CUFE means “code for the physical location of the facility”. If everything is in one address, there is only one CUFE.
4. When must I verify if the client I am operating with is registered in RENPRE? Is it when I issue an invoice, the packing slip, when the goods leave the plant in the track, when the goods arrive to the client`s plant? Does it depend on who hired the driver?
In all those moments the subject must be registered. If he wasn’t, it would be a violation of the regulations in force.
5. Products in List 3. We understand that it is still not compulsory to present the quarterly reports for their movements.
The list 3 is still not compulsory, except for Nitroethane, Methylamine and Benzaldehyde.
6. A company has a production plant and a development laboratory in different places. The supply purchases are received in the plant but “samples” or small amounts of supplies are sent to the laboratory. They are currently registered only as operators. Must they also register as carriers in the case of this minimum amounts? Must they have two CUFEs?
They must have two CUFEs, one for the plant and one for the laboratory. As regards transportation, there are two ways:
1) With company vehicles declared in RENPRE. In this case, a driver is not specified.
2) With an authorized driver registered in RENPRE. In this case, the CUFE of the transportation company is specified in the event.
7. Which is the valid prove that the client I am operating with is registered in
RENPRE? The webpage search or the certificate?
You must consult in the webpage www.renpre.gov.ar in the section Operators Search
Reports of Substance Movements
F.A. M. agreement
8. How must I present the first 2014 quarterly report?
The first 2014 quarterly report is presented through the National Traceability System. This is sent from the option quarterly report in the web page. You must load the initial stock at the beginning of such period and then register all the movements of the trimester. The report must be handed in printed in the register with all the pages signed, along with the corresponding form.
9. Where can I check the operator category I belong to?
The agent type or operator is specified in the certificate. If there are asterisks in the specification, it is a general operator. In the other cases, it is explicitly identified, for example, little operator, driver, etc.
10. When must I load the initial stock?
The initial stock is loaded once when the traceability system is initially used. The “events” add and subtract the initially loaded stock.
11. Manufactures “by an outside processing supplier”. A company gives to a third party (outside processing supplier) a product to be processed or transformed into another product that is given back to the first. Must the first operator have its own CUFE in the plant where the “outside processing” is done or must he use the CUFE of the other? What events must each one of them report?
Everyone who takes part in the process must have CUFE as it specifies a geographical location where there are monitored substances or products.
The following events are used in the outside processing:
Delivery for outside processing: the company that sends the substance or product to be processed outside reports the event.
Reception for outside processing: the other that will manufacture the substance or product receives it.
Delivery of outside processed product: it is loaded by the third party when it delivers the substance or product outside processed.
Reception of outside processed product: it is loaded by the company when it receives the substance or product manufactured by the third party.
12. A good is transported from the manufacturer/supplier plant to someone else`s store, where it temporarily stays. Then it is transported from the store to the client`s plant. Must the supplier get a CUFE in the third party`s store?
Yes, the third party`s store must be registered in traceability as an establishment/subsidiary (subCUFE) of the manufacturer/supplier.
13. If I rent my store to many companies, must I be registered in traceability?
If so, what events must I use?
Yes, you must be registered in the traceability system. The owner of the store renting it to one or many companies must have CUFE and must use the following events:
Initial stock register: in order to register all the substances and products in the store regardless who is the owner.
Reception for storage: reception of goods from any of the tenants.
Delivery for storage: delivery of goods by any of the tenants.
14. Duties of the drivers. Must the driver`s stores have CUFE?
Yes. They must have a main CUFE and, if they have subsidiaries, they must have subCUFEs.
15. For exceptional circumstances an operator must move his goods to a store of his own, where they stay for some hours. Must this store have CUFE?
Yes. It is a SubCUFE (Establishment/Subsidiary) of the main CUFE.
16. Must the operator handing in the load report the net weight/quantity to be transported to the driver?
Yes. The driver must be reported the net weight/quantity and which is the product/substance to be transported.
17. Import for resale: the container is unloaded from the ship and is transported to a bonded warehouse (it is not deconsolidated there, as some of the goods inside are from the company and some are from others). Must the company have a CUFE for the stay of the goods in that Customs bonded warehouse?
No. The company must declare as origin CUFE the one of the origin country and destination CUFE the deposit where the goods are taken.
18. Exports. The system asks to complete the field “border crossing”. Is it compulsory to fill it in?
Yes, it is compulsory. The list is currently in the system:
Border crossing entry:
Shipping license document
DJAI (affidavit prior to import)
Certificate number of RNPQ (National Registry of Chemical Precursors)
RIO GRANDE AIRPORT
SAN MARTIN D. L. ANDES AIRPORT
19. What is the difference between product and Substance?
Substances are the precursors of lists I and II in natural state.
The products are the mixtures that have one of the substances included in lists I and II in a concentration higher than 30% w/v (weight in volume) or a mixture of substances of lists I and II when the sum is higher than 30% w/v.
20. Some substances or mixtures are not well defined, for example, hydrochloric acid or ammonia. They should be equally considered substance or mixture.
The mixtures that have hydrochloric acid or ammonia are monitored according to what was decreed in the previous answer.
The solutions of hydrochloric acid and ammonia will be monitored when they have a concentration higher than 20% w/v.
21. What about the products that can only be reported in kilograms and the associates work with them in liters or the other way around?
The products keep the measure unit of the substance used for their production. It is necessary to use that unit in all the movement reports.
If there are 2 substances with different measure units, the measure unit used will be the one of the substance in higher percentage.
If there are products with 2 substances with different measure unit in the same percentage, the measure that prevails is the Kg.
If the product is commercialized in a different measure unit, the unit conversion must be done in order to be loaded to the system.
Anyway, the measure unit of each product can be looked up in the electronic data catalog.
22. When an own product is created, what code must be used? Is it given by RENPRE?
The product code is given by the National Traceability System only if the product is formally declared in the RENPRE through the procedure Product Register.
In the commercial operations of a product manufactured by other the product code used is the one given to the manufacturer as he is the one that manufactures/produces it.
23. Must I register the products I manufacture?
Yes. It must be done in RENPRE through the procedure Product Register. That product will be in the traceability system.
24. Must I register the products I trade?
No. The products you trade must be registered by the manufacturer.
25. When a product is registered in RENPRE, must the industrial formula be revealed?
No. It must only be declared the quantity of controlled substances the product has.
26. When is something considered a pure substance and not a product?
It is considered that a product is actually a pure substance when the concentration is 95% or higher. If you cannot find the product in the traceability system and it has a substance concentration of 95% or higher, you must load the pure substance in the event. The event code starts with 888.In the name it is specified that it is a pure substance, for example, ACETONE (PURE SUBSTANCE).
27. How do I register the movements of the products/mixtures I do not produce?
In order to register the products you do not produce you must ask your supplier the product code or you can look it up through the option “electronic data catalog-electronic catalog search by GTIN/Product code”. If you cannot find the product because your supplier has not registered it in RENPRE yet, you must attach a note explaining that the mixture has not been registered in RENPRE and an appendix 14 specifying the movements of the product. Both reports, the PDF you print from Traceability and the appendix 14, will be handed in with only one Form F04. We remind you that if a product has a substance concentration of 95% or higher, it is considered PURE SUBSTANCE. They have their own generic code and they are identified. For example, ACETONE (PURE SUBSTANCE).