ANMAT Order No 5260/2008  
HAVING REGARD TO Laws Nos 16.463, 17.818, 19.303; Decrees Nos 9763/64, 150/92, 
1890/92, 177/93;  Joint Resolutions Nos 268/92 (M.S. and A.S.) and 470/92 (M.E. and O.S.P.) and No 
748/92 (M.S and A.S.) and 988/92 (M.E. and O.S.P.), De cree No 1490/92, Common Market Group 
(Grupo Mercado Común,  GMC) Resolution No 88/93, transposed into national law through ANMAT 
Order No 5219/97, Order (ANMAT) No 2819/04, the reports from the PICs (Pharmaceutical Inspection 
Cooperation Scheme) and dossier  1-47-1110 -419-08-1 from the Register of this National Authority, and  
WHEREAS:  
The active ingredients intended for use in the manufacture of medicines are included in the 
scope of Articles 1, 2 and 3 of Law No 16.463;  
Article 1 b) of Decree No 150/92 defi nes an active ingredient or pharmaceutical drug as “any 
chemical or mixture of related substances of natural or synthetic origin which, having specific 
pharmacological properties, is used in human medicine”.  
Chapter III (Articles 7, 8 and 9) of the Decree referred to in the previous recital lays down 
the requirements to be met by establishments that manufacture and/or portion drugs and medicines.  
In accordance with Decree No 1490/92, which instituted it, the National Medicines, Foods 
and Medical Technology Board (ANMAT) is responsible for all matters relating to the monitoring and 
inspection of the healthfulness and quality of drugs, chemicals, reagents, pharmaceutical forms, 
medicines, elements of diagnosis, biomedical materials and technology and all other  products used and 
applied in human medicine and to the control of the activities, processes and technologies used in the 
supply, production, manufacture, portioning, import and/or export, storage and sale of products, 
substances, elements and materials co nsumed or used in human medicine (Article 3(a) and (e)).  
In keeping with the above responsibility Decree No 1490/92 gives ANMAT powers to 
authorise and register the said products, oversee compliance with the health and quality rules laid down for 
them and grant authorisation to the natural or legal persons involved in the supply, production, 
manufacture, portioning, import and/or export, storage and sale of the same.  
Such activities are primarily intended to guarantee the effectiveness, safety and quality o f the 
products consumed by the public.  
In order to perform these supervisory activities, provided for in Article 8(n) of Decree 
1490/92, it is necessary to have a model that ensures that industries are supervised using harmonised 
criteria as well as neutra lity, symmetry and reciprocity in the treatment and application of the regulatory 
standards on the production of medicines from the raw material to the finished product.  
It was with this in mind that ANMAT Order No 2819/04 was enacted, adopting the 
recomme ndations in force concerning Good Manufacturing and Supervisory Practices for 2003, approved 
by the World Health Organisation, and reports by the Pharmaceutical Inspection Cooperation Schemes: 
PE 009 -1 and ICH —International Conference on Harmonisation — Guide Q7A on Good Manufacturing 
Practice for active pharmaceutical ingredients (API) included as Annex VI, compliance with which – or 
with any rules that may replace it in future – is compulsory for establishments engaged in the 
manufacture, preparation, portioning, import and/or export of active pharmaceutical ingredients (API).     
In accordance with its duty of verifying compliance with Good Manufacturing Practice, this 
Authority draws attention to the need to update the legislation in force and considers it appropriate to 
make use of the powers conferred by Article 8 (ñ) of Decree 1490/92 and Decree 341/92, which authorise 
it to adopt the most timely and appropriate measures to protect the health of the population.  
Article 6(2) of Joint Resolution No 268/9 2 (M.S. and A.S.) and No 470/92 (M.E. and 
O.S.P.) amended by the similar instrument No 748/92 (M.S. and A.S.) and Nº 988/92 (M.E. and O.S.P.) 
specifies the professional qualifications required for access to technical management positions as regards 
activit ies relating to pharmaceutical drugs or active ingredients in medicines.  
Since our country is a signatory of the United Nations Single Convention on Narcotic Drugs 
of 1961, its amended Protocol of 1971 and the Convention on Psychotropic Substances of 1972,  it must 
submit to the International Narcotics Control Board (INCB), before July 31 each year, its forecasts for 
imports and local manufacture of narcotics and psychotropic substances for the following year.  It is necessary to lay down rules that increase the predictability of the system under which 
companies engaged in activities of manufacture, preparation, portioning, import and/or export of active 
pharmaceutical ingredients (API) are registered.  
Common Market Group Resolution No 88/93 adopted the Techni cal Document known as 
“Authorising the operation of pharmaceutical chemical plants”, and this was transposed into national law 
by ANMAT Order No 5219/97.  
In accordance with the previous recital, it has become necessary within the framework of 
MERCOSUR to i mplement a first phase in relation to compliance with the rules laid down in the 
Document “Authorising the operation of pharmaceutical chemical plants”, by means of the authorisation 
of the plants in the sector by the Health Authority.  
The authorisation of  establishments that manufacture/prepare, package, import and/or export 
medicines includes requirements that apply equally to those engaged in the manufacture, preparation, 
portioning, import and/or export of active pharmaceutical ingredients (API).  
The Na tional Medicines Institute and the Legal Affairs Directorate have taken the 
appropriate action.  
This action was taken under the terms of Decree No 1490/92 and Decree No 253/02,  
Therefore,  
THE INSPECTOR OF THE NATIONAL MEDICINES, FOODS AND MEDICAL TECHNOLOG Y 
BOARD  
DECREES:  
Article I — This Order shall apply to the activities of manufacture/preparation, distribution, import, 
export and/or storage under the national jurisdiction or for the purposes of inter -jurisdictional trade of 
active pharmaceutical ingredi ents of chemical synthesis and the natural or legal persons involved in such 
activities.  
Article 2 — The activities referred to in the previous article may only take place with the authorisation 
and under the control of this National Authority, in establis hments authorised for the same, which must 
comply with all of the requirements laid down in this Order and with the Good Manufacturing Practices 
included in Annex VI to ANMAT Order No 2819/04 or those that may replace them in future.  
Article 3 — For the pu rposes of this Order the following definitions are hereby adopted:   
a) CONTRACTED PRODUCER:  Establishment authorised by ANMAT that performs some of the 
stages in the manufacturing process as agreed with the licensed undertaking under a contract.  
b) UNDERTA KING LICENSED TO PRODUCE, PORTION, IMPORT AND/OR EXPORT:  natural or 
legal person authorised by ANMAT to manufacture, produce, portion, import and/or export active 
pharmaceutical ingredients (API).  This party is responsible for the release of the batches in  accordance 
with the quality targets required under this Order.  
c) MANUFACTURE/PRODUCTION:  Total synthesis of an active pharmaceutical ingredient (API) or 
partial synthesis from a specific element, which may include the following operations:  receipt of 
mater ials, production, packaging, repackaging, labelling, relabelling, quality control, dispatch, storage 
and distribution.  
d) PORTIONING:  all operations of receipt of an active pharmaceutical ingredient, division into smaller 
packages or units, packaging, labelli ng, quality control, dispatch, storage and the associated controls.  
e) ACTIVE PHARMACEUTICAL INGREDIENT (API):  Any substance or mixture of substances 
intended for use in the manufacture of a medicine or medicinal preparation and that thus becomes an 
active in gredient in the said product, including those classified as psychotropic under Law No 19.303 and 
its annexed lists or as narcotics under Law No 17.818 and its annexed lists.  
These substances have pharmacological properties or other direct effects on the di agnosis, cure, relief, 
treatment or prevention of illnesses, or influence the structure and function of the human body.  f) INTERMEDIARY:  a material prepared during the stages of processing of an active pharmaceutical 
ingredient that undergoes additional mo lecular changes before being transformed into an active 
pharmaceutical ingredient . Intermediaries may or may not be isolated.  
g) BATCH:  specific quantity of material produced during a process or series of processes that is 
homogeneous within the specified limits.  
In the case of continuous production a batch may correspond to a defined proportion of the production.  
The size of the batch can be defined either as a fixed quantity or as the amount produced over a given 
period of time . 
h) PACKAGING AND PACKING M ATERIAL:  elements intended to protect an active pharmaceutical 
ingredient during packaging, storage or transport.  
i) BATCH NUMBER:  unique combination of numbers, letters and/or symbols identifying a batch and 
which can be used to determine the history of t he production and distribution.  
Article 4 — The undertakings referred to in Article 2 of this Order must have a pharmaceutical 
professional as the technical manager of the undertaking, and sufficient staff with the appropriate training, 
so that the quality  of the active pharmaceutical ingredients (API) and the performance of the quality 
controls required under this Order can be ensured at all times.  
Article 5 — The undertakings referred to in Article 2 of this Order must have a minimum infrastructure 
made u p of one production and portioning area, storage area and a properly -equipped in -house quality 
control laboratory, in accordance with the activity for which the undertaking is authorised, and may 
contract out to a third party the quality controls referred to in Article 13 of this Order.  
Article 6 — The active pharmaceutical ingredients prepared and/or imported must meet the technical 
quality specifications laid down in the current Farmacopea Argentina  (FA), the British Pharmacopoeia 
(BP), the European Pharm acopoeia (EP), the Farmacopeia Brasileira  (FB), the Farmacopea de los 
Estados Unidos Mexicanos  (FEUM), the International Pharmacopoeia (WHO), the Japanese 
Pharmacopoeia (JP) and the United States Pharmacopeia National Formulary (USP -NF), and/or, failing 
this, they must comply with the manufacturer's specifications.  
Article 7  — The undertakings mentioned in Article 2 of this Order and which are currently operating 
must comply with the provisions laid down herein within a period of ninety (90) days following its 
publication in the Official Gazette by applying for the corresponding authorisation . To this end they must 
submit to ANMAT the required information shown in Annex I, which is an integral part of this Order . 
Article 8 — Undertakings with authorisation t o manufacture medicinal preparations shall be automatically 
authorised to perform activities of portioning , import and/or storage of active pharmaceutical ingredients 
for their own use, and must comply with the technical requirements laid down in this Orde r. 
To monitor compliance with the provisions of the previous paragraph ANMAT, through the National 
Medicines Institute (INAME), will perform the inspections it considers necessary in order to determine 
the exactitude of the information declared.  
Article 9 — Changes to the physical structure of the authorised establishments and facilities must be 
authorised by this National Authority, which will check them beforehand by means of an inspection.  
Article 10.  — An undertaking authorised to produce active pharmac eutical ingredients (API) may 
delegate the performance of any of the stages in the manufacturing process to other producing 
undertakings, authorised by ANMAT, which will be known as “Contracted Producers”.  
The legal relationship between the licensed undert aking and the contracted producer must take the form 
of a written contract setting out the stages in the production process for which each of the parties is 
responsible and must be signed by the Technical Managers and legal representatives of both 
undertak ings.  
Article 11.  — The licensed undertaking that contracts out production must keep up -to-date records of the 
work contracted out, indicating the batches manufactured and released in order to document and 
guarantee the traceability of the same.  
Article 12 . — The licensed undertaking and the contracted undertaking(s) shall be jointly and severally 
responsible for the activities of manufacture, preparation, portioning, import and export of active pharmaceutical ingredients, as well as for compliance with the  Good Manufacturing Practices.  
Article 13.  — The authorised undertakings may contract out to third parties those quality controls that 
require special facilities, equipment and/or procedures.  
The contract between the licensed undertaking and the contractor  must be made in writing and shall set 
out all of the checks involved for which each party is responsible.  This must be signed by the Technical 
Managers of the parties involved and their legal representatives.  
The contracted laboratory shall also be subjec t to inspections by this National Authority.  
Article 14.  — Undertakings authorised to produce active pharmaceutical ingredients may obtain 
certification for the products produced and sold following evaluation by this National Authority of the 
documentation  required in Annex II, which is an integral part of this Order . These active pharmaceutical 
ingredients shall form part of the update to the Farmacopea Argentina  and the National Programme of 
Development of Reference Substances.  
Article 15.  — To be registe red and recorded.  To be communicated to the Chambers and other 
Professional Bodies.  To be notified to the relevant parties.  To be given to the National Directorate for the 
Official Register for publication.  Once completed, to be permanently archived.  — Ricardo Martínez.  ANNEX I  
APPLICATION FOR AUTHORISATION OF UNDERTAKING  
Messrs …………………………………………. and ………………………………………..., in our 
capacity of owner/legal representative and technical manager, respectively, of the undertaking  
……………………………………………………………. are writin g to you to request inspection of our 
establishment to verify compliance with the Good Manufacturing Practices of active pharmaceutical 
ingredients (API), and declare the information provided below to be exact:  
1. IDENTIFICATION OF THE UNDERTAKING  
- Name/Bus iness name:  
- Legal representative (attach documents demonstrating legal status):  
- Tax number:  
- Registered address of the head offices of the undertaking (plants, storage facilities, etc.):  
- Telephone and fax:  
- E-mail:  
2. THIRD -PARTY CONTRACTORS:  
- Name/Business n ame:  
- Legal representative (attach documents demonstrating legal status):  
- Tax number:  
- Registered address of the head offices of the undertaking (plants, storage facilities, etc.):  
- Telephone and fax:  
- E-mail:  
3. ACTIVITIES PERFORMED BY THE UNDERTAKING:  
- Prepar ation:  YES/NO  
- Portioning:  YES/NO  
- Import:  YES/NO  
- Export:  YES/NO  
 
4 PRODUCTS INVOLVED IN THE MANUFACTURING, PRODUCTION, PORTIONING, IMPORT, 
EXPORT AND/OR SALES -RELATED ACTIVITIES PERFORMED BY THE UNDERTAKING  
5 IDENTIFICATION OF THE TECHNICAL MANAGER:  
 
- Name and s urname:  
- National identity card number:  
- Registration number:  
- Attach a certified photocopy of the qualification and registration  6. PHYSICAL STRUCTURE:  
- Attach original and two copies of most up -to-date plans, at scale 1:100:  
7. PRODUCTION AND CONTROL EQUI PMENT  
- List of items of equipment used:  
 
 
 
 
 
 
 
 
 
SIGNATURE  
OWNER/LEGAL REPRESEN TATIVE   
SIGNATURE  
TECHNICAL MANAGER  
 
 ANNEX II  
CERTIFICATION OF ACTIVE PHARMACEUTICAL INGREDIENTS MANUFACTURED IN THE 
COUNTRY  
1.- DETAILS OF THE PRODUCT:   
Product name :  
ATC pharmacological classification:  
2. - DETAILS OF THE APPLICANT LICENSED UNDERTAKING:  
Name or business name:  
Registered address:  
Registered address of the manufacturing plant:   
Telephone and fax:   
E-mail  
Website:   
Tax number:   
Number of authorising o rder:  
3 DETAILS OF THE TECHNICAL MANAGER:   
Name and surname:   
Type and number of document:   
Order authorising the technical manager:  
4 DETAILS OF THE LEGAL REPRESENTATIVE:   
Name and surname:   
Address:   
Telephone and fax:   
Type and number of document:  
5 – CONTRAC TED MANUFACTURING UNDERTAKING, IF ANY:   
Name or business name:   
Registered address:  
Registered address of the manufacturing plant:   
Telephone and fax:   
E-mail:   
Website:  Number of Order authorising the undertaking:   
Name of technical manager of manufacturi ng undertaking:  
Number of Order registering the technical manager:   
Contract:  
6. - QUALITY CONTROL BY THIRD PARTIES  
Name or business name of contracted laboratory:  
Address:  
Telephone and fax:  
Name of technical manager of contracted laboratory:   
Copy of the  contract:  
7. -REQUIRED TECHNICAL DOCUMENTATION:  
MANUFACTURE  
• Description of manufacturing process and process controls  
• Flowchart  
• Critical Control Points  
• Validation or evaluation of the manufacturing process  
• For sterile drugs: validation of sterilisation pr ocess  
• Development of the manufacturing process  
• Expected yield   
• GENERAL INFORMATION AND CHARACTERISATION  
• Nomenclature  
• Structure:  Molecular weight, molecular and structural formula  
• Properties:  General characteristics, solubility, crystalline form, chirality,  particle size  
• Elucidation of structure and other characteristics   
• CHECKS ON INTERMEDIARIES AND STARTING MATERIALS  
• Sampling techniques  
• General features  
• Analytical methods   
v Physical tests   
v Identification tests   
v Tests of purity   v Evaluation methods  
• Specifications  
• Justification of specifications  
• Elucidation of structure and other characteristics of impurities and intermediaries, if any  
CHECKS ON API  
• Sampling techniques  
• General features  
• Analytical methods   
v Physical tests   
v Identification tests   
v Test s of purity   
v Evaluation methods  
• Validation of analytical methodologies  
• Specifications  
• Justification of specifications  
• Elucidation of structure and other characteristics  
• Test protocols of three batches  
If product control methods are codified, please indic ate the Pharmacopoeia in which they appear.  
REFERENCE MATERIALS/STANDARDS  
Requirements in accordance with Annex 4 of ANMAT Order No 2819/04  
PACKAGING AND PACKING MATERIAL  
• Description  
• Physical -chemical and functional checks  
• Specifications  
• Justification of s pecifications  
 STABILITY  
• Number of batches examined  
• Environmental conditions under which examination took place  
• Description of final packaging  
• Test method  
• Validation of test method  • Frequency of checks  
• Designated lifespan and method of preservation.  Frequen cy of additional checks  
• Summary of report – Conclusions  
• Post-registration stability protocol  
• Stability data  
For all items, provide documentation supporting the tests performed and facilitating traceability of the 
information.  
SIGNATURE  SIGNATURE  
OWNER/LEGA L REPRESENTATIVE  TECHNICAL MANAGER: