The formal application process starts when a pharmaceutical company takes the compilation of documents known as the application dossier to the COFEPRIS office. The reviewers at the COFEPRIS will read everything very thoroughly and will address any question they might have about the data on the dossier in the form of a letter, commonly called deficiency letter, officially called prevención in Mexico. Deficiency letters are not always issued, and most of them can be avoided by following all the guidelines, submitting complete information, and avoiding common silly mistakes.
If your product falls into the category of ‘new molecule’, you have to request a meeting with the New Molecule Committe before submitting the application.
These are the cases in which you drug will be considered a “New Molecule”
- New drug substances (new in the world or new for Mexico)
- New combinations of drug substances (for Mexico)
- New indications
- Other special cases (e.g. similar biotherapeutic products)
Just a year ago, an average application could take anything between 1 and 4 years to be reviewed and approved. With some key changes implemented lately, such as the pre-revision process by Third Authorized Parties, or the Agreement for Innovation, timelines are decreasing dramatically, to just some months to a year.
The marketing authorization is granted for a period of five years. Submission for registration renewal must be filed at least 6 months before expiry.
Preparing the submission dossier
The structure of the submission dossier will depend on the type of product that it is intended to be registered.
New Molecules
Module I. Legal/Administrative information
Module II. Quality information
Module III. Preclinical studies
Module IV. Clinical studies
Generic drugs
Module I. Legal/Administrative information
Module II. Quality information
Module III. Bioavailability and/or bioequivalence
Vaccines
Module I. Legal/Administrative information
Module II. Quality information
Module III. Preclinical studies
Module IV. Clinical studies
Orphan drugs
Module I. Legal/Administrative information
Module II. Quality information
Module III. Justification of ‘orphan drug’ status
Module IV. Preclinical studies
Module V. Clinical studies
Checklists of documents for each module
Module I. Legal/Administrative information
1. Form.
2. Proof of payment of fee.
3. Sanitary authorization. (licencia sanitaria) If the manufacturing site is located outside of Mexico, provide licence, certificate or other document authorizing the site to the activities related to manufacturing of pharmaceutical products of interest, issued by the competent authority of the country of origin, legalized or apostilled, translated to Spanish by an official translator (perito traductor).
4. ‘Responsible sanitario’ notice.
5. Labeling texts (if applicable).
6. Complete and summarized prescription information.
7. GMP certificate for manufacturing site of API.
8. GMP certificate for manufacturing site of finished product.
9. GMP certificate for manufacturing site of diluent (if applicable).
10. For drug products manufactured outside of Mexico: Certificate of Pharmaceutical Product (CPP) of origin, apostilled or legalized, with official translation (perito traductor). The CPP is a document that certifies that a pharmaceutical product is registered and/or commercialized in a country. Representation letter, assigning the legal representative of the foreing company in Mexico. It is adviced to write a wide power of representation letter, with a minimum validity period of 5 years.
11. Commercial name.
12. Intellectual property information.
13. Information on the waiver for the local manufacturing facility requirement.
Module II. Quality information
1. API
1.1. Manufacturing information
1.2. General information
1.3. Quality control
1.3.1. Literature/Pharmacopoeial references. Specifications. Analytical methods. Validation reports. Certificates of analysis (CoAs).
2. Excipients and additives
2.1. For new additives, usage safety information
2.2. Quality control
2.2.1. Literature/Pharmacopoeial references. Specifications. Analytical methods. Validation reports. Certificates of analysis (CoAs).
3. Finished product
3.1. Pharmaceutical development
3.2. Formula
3.3. Manufacturing information
3.3.1. Manufacturing/packaging order, in-process controls.
3.4. Quality control
3.4.1. Monograph
3.4.2. Specifications
3.4.3. Analytical methods and validation reports (if applicable)
3.4.4 Certificates of analysis (CoAs).
3.5 Stability
3.5.1 Stability protocol
3.5.2. Tabulated stability data
3.5.3 Analytical evidence for first and final testing points.
3.5.4 Conclusions
4. Packaging materials
4.1. Description and capacity of primary packaging materials.
4.2. Description and capacity of secondary packaging materials.
4.3. Description, capacity and information of any additional materials or devices.
Module III. Preclinical studies (for new molecules, vaccines, orphan drugs).
1. Preclinical studies
1.1. Pharmacodynamic studies
1.2. Pharmacokinetic studies
1.3. Toxicology
Module IV. Clinical studies (for new molecules, vaccines, orphan drugs).
1. Clinical studies
1.1. Phase I studies
1.2. Phase II studies
1.3. Phase III studies
1.4. Phase IV studies (if applicable)
1.5. For combination of two or more drugs: risk-benefit assessment.
Module III. Bioavailability and/or bioequivalence (for generic drug products)
1. Type of test
1.1. A
1.2. A (3)
1.3. B
1.4. C
Last update: October 2013
Regulatory Affairs in Latin America 
Please let me know, what is A, A(3), B & C in the Module III of generic drugs
Hello, Ajay!
Thank you for your very good question. Here’s the answer:
Test A: GMP verification (manufacturing authorization -for national manufacturing- and GMP certificate -for foreign manufacturing)
Test A (3): Size of equivalent particle
a. Size of particle – Range of particle size.
b. The type of test is A*. (Measurement of the particle size with the cascade method, with a particle diameter from 0.5 to 5 μm) It can be performed by the manufacturing lab, as it is a QC test.
Test B: Dissolution profile
Test C: Bioequivalence studies
Thanks for the information.
I am not completely understand about Test A & Test A(3). Can you pls elaborate..
When we will go to do Test A / Test A (3), what type of products
Regards,
Ajay
Dear Ajay,
The requirement for Test A means that you need GMP certification (to assure that your manufacturing methods produce the desired outcome, etc.) and Test A (3) is the analysis of the size of particle. The analysis of size of particle, when applicable, is very important: increased absorption due to reduction of particle size is a result of increased dissolution, which is in turn the result of a larger specific surface area being exposed to the fluids of the gastrointestinal tract or other sites of administration. (and vice versa)
These tests apply to generic drug products. The idea is to prove bioequivalence to the reference product. The particle size test, of course, will depend on the dose form; you can measure this parameter in aerosols, powders, tablets, etc. but it would be hard to do it on a solution 🙂
Have a great weekend!
Maria
Hi there
Just wondering about abreviated procedure in Mx- is this available?
Emma
Hi, Emma!
There is no general abbreviated procedure in Mexico, meaning that a complete document dossier has to be submitted in every case. With that said, there are some ways to reduce timelines to approval, such as using an Authorized Third Party to pre-revise the dossier https://latampharmara.com/mexico/authorized-third-parties/ or going through the “Agreement for Innovation” route, in which innovative products that comply with certain requirements enter the evaluating function of the agency through a separate expedite track.
Have a great day!
Maria
Hi Maria!
Thanks for the info!
What about the timing.. Do you do your new molecule meeting first and then start working with the party to review the dossier before the submission?
or is it more activity in parallel.
Also, I would like to know about transfer of MAA from companies – in Europe this is of course a type 1 variation, but is a similar approach valid in MX!
Really appreciate your input.
Best Wishes
Emma
Hi Emma!
Ideally, you would get in touch and choose an authorized third party before the meeting with the New Molecule Committee, given that they can generally assist you (independently from the pre-revision function) with their local expertise at the time of requesting, preparing and conducting the meeting.
The pre-revision will be conducted on the finished dossier. They will make sure that you included all the necessary information and documents, including the report of the New Molecule Committee and the your addressing of any questions that the NMC might have had.
The times of revision by the Authorized Third Party will depend on the chosen consultant and the agreed terms, which of course will be depending on the complexity of the product and the completion of the information you provide. The timing scale is generally a matter of weeks rather than days or months.
Regarding the MAA transfer, the variation is codified as COFEPRIS-10-001 CESIÓN DE DERECHOS DEL REGISTRO SANITARIO DE MEDICAMENTOS (transfer of rights on sanitary registration of drug products) as is classified as an administrative variation, no technical documents are required, although proposed new labeling texts have to be submitted.
Timelines for approval can be of up to 6 months, but this process can also be expedited to a scale of weeks if pre-revision from an Authorized Third Party is granted. Transfer is not possible if the registration is undergoing variation or renewal of certificate process, you would have to wait until those are finished to apply for the change.
About grace periods for the existing stock, the new MAH can sell out existing stocks of former MAH labeled product within 10 months.
Have a nice Wednesday!
Maria
Hai Maria,
Thanks for the info!!
If the product is manufactured in outside of Mexico and register the product in Mexico with the help of local local distributor and local legal representative, who will be the marketing authorization holder?? manufacturer or local legal representative??
Regards,
Ajay
Hi Ajay!
The marketing authorization holder will be the manufacturing site outside of Mexico.
Thanks!
Dear Maria,
My question is related to that of Ajay:
Did i understand it correctly that if the Company is located in the EU they need a local Distributor and a local legal representative for the MAA in Mexico but the final MAH will be the European Company?
I am looking forward to your response. PS: Your Website is very helpful!
Evanthia
Hi Maria,
Please let me know the registration fee and timelines to get approval?
Regards,
Ajay
Hello, Ajay!
Timelines for approval are uncertain and highly depend on the case. You can find some indicatives in some of the slides on the presentation on Mexico on the homepage of this website.
The fees will also vary depending on the case. The following fees are valid for the year 2014 and are expressed in Mexican pesos (MXN).
Generic drug products: 62,270 MXN
Innovative drug products: 111,341 MXN
Homeopatic, herbal and vitamin products: 14,807 MXN
Have a great week!
Maria
Hi how do we register a new drug in mexico? The rules and regulations for a canadian made medicine? The export process ? Hoping for your immediate response. Thanks
Hi, Mark!
The rules and regulation for Canadian medicines are the same than for any other countries (which you can read above) with some exceptions:
– GMP certificates issued by Health Canada are accepted, so COFEPRIS wouldn’t have to inspect your site if it has already been certified by your health authority.
– In the case of some innovative products (newly developed and not present in Mexico) you can apply for expedite registration under the “Agreement for Innovation”.
I can help you mainly with topics of regulatory affairs in Latin America, the exporting process depends on the country of origin, for the case of Canada for example, you can find some information here: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/import-export/index-eng.php
Why don’t you send me an email to maria@latampharmara.com and we can start from there?
Have a great day!
Maria
Hi, as part of our project we are required to export a pharmaceutical product in Mexico from Canada, specifically a diclofenac topical solution (NSAIDs ). Can I have a favor do you have any idea how to export a medicine that is manufactured here in Canada? It’s been few weeks we’ve been looking on google how to register a medicine but still we ended up being depressed. The things we need to know are the following ,drug registration ( time approval) and regulatory affairs, tariff, distribution system, legal considerations, taxes and several facts, process to export a medicine coming from the same continent North America. I hope you could help us. Hoping for your immediate response. Please 😦
Hi, Mark! Don’t stress out, we’ll figure something out.
Why don’t you send me an email to maria@latampharmara.com ?
Cheers,
Maria
Dear
Hi~! We are to export our drug (New Molecule) to Mexico and Colombia. Our first target is Mexico. So, we plan to get the drug approval by COFEPRIS first and one by INVIMA next.
Meanwhile, I heard that the Interagency Agreement between Sanitary Agencies of the Memebers of the Pacific Alliance was signed in June, 2013. As a consequcence it is told that COFEPRIS and INVIMA recognize sanitary registrations issued by both agencies.
Then, if our drug is approved by COFEPRIS and we get our drug’s sanitary registration issued by COFEPRIS, don’t we need to take steps to get the drug registraion by INVIMA?
We’d like to how easy it is to get drug approval in Colombia if the drug is registered by COFEPRIS.
Please give a tip.
Sangmi
Dear Sangmi,
Thank you for your very interesting question. I am aware of this agreement but unfortunately don’t know of anyone with experience of benefiting from it. I would very much appreciate if anyone would any info would share some thoughts.
Have a great weekend!
Maria
Hi,
Can you please provide the format of the Form that is mentioned in the Module 1.
Also please confirm whether COFPERIS accepts a FULL CTD dossier or the dossier needs to be as per mexican guidelines only.
Thanks in advance
SM
Hi Sulekha!
Thank you very much for your question and your interest in my website. You should tailor your dossier to the Mexican requirements; even if all the required information is included you shouldn’t just submit a dossier that has been made for another market. Extra information can be confusing, raise additional questions, and your dossier might be rejected for not having a relation with what COFEPRIS wants to see.
Also, keep in mind that the full dossier must be in Mexican Spanish.
About the application form, it’s the first of the list in the following website: http://www.cofepris.gob.mx/TyS/Paginas/Formatos.aspx and it’s in Spanish. The Excel file is the form, whereas the pdf are the guidelines to fill it in.
Have a great weekend!
Maria
Hi Maria,
There is any pricing and reimbursement in Mexico? if yes, what is the process?
Thanks in advance…
Regards,
Ajay
Dear Ajay,
This is a question for a market access expert. My specialty is regulatory affairs. I suggest you read this paper: http://www.oecd.org/mexico/38097348.pdf It is a little old and many things are outdated but you can get a general idea to start with.
Hi Maria.. we are filing a new drug but also referencing an old product in our new file. This product needs to be transferred between companies, and a new manufacturer needs to be added to the MAA of the “old product”. My idea was to 1. do the transfer, and then 2 change the manufacturer..ANy advice??
Dear Emma,
I think yours is a good approach for two reasons.
Firstly, a Marketing Authorization Transfer is an administrative variation, whereas the addition of a new manufacturing site is a technical variation. Administrative variations are simpler to submit and take less revision time than technical ones. For both cases, you can use the Authorized Third Party scheme to expedite revision times. You can prepare the submission for the first variation, which requires exclusively legal and administrative documents in a short time, and use the revision time to get ready for the more burdensome, complicated submission of manufacturing side addition.
Secondly, if you did it in the opposite order, you would need to have a manufacturing contract between the old Marketing Authorization Holder and the new manufacturer, which can be completely avoided if you proceed as you suggest.
Keep in mind that marketing authorization transfer is not possible while other variations or a product renewal are ongoing.
Looking forward to hearing your thoughts!
Hi Maria! Really you are a wealth of knowledge!! What would we do without you!!
Next I am thinking that it might be a good idea to go to a manufacturing site that is gmp inspected already by fda, pmda health canada.. Were there other reference agencies that we could use to avoid this cofepris inspection?? In any case we will soon not have manufacturing capabilities in Mex so we will need to find somewhere else to release the product..
Do you know how long this administrative variation could take using the atp??? Are we talking 6-8 mnths for total process??
Thanks alot
Hi, Emma!
The GMP certificates that are accepted by COFEPRIS are those issued by FDA (USA), ANVISA (Brazil), Health Canada (Canada), EMA (EU), Pharmaceutical and Safety Bureau (Japan) and TGA (Australia). In some cases, GMP certificates issued by the HA of origin, if different from the ones mentioned above, can be accepted. Please, refer to https://latampharmara.com/2013/10/18/mexico-new-guidelines-for-the-acceptance-of-gmp-certificates/ for more detailed info. Remember that the API manufacturer will also have to comply with this GMP verification guidelines.
The administrative variation of change of marketing authorization holder takes 4-6 months without the pre-revision by the ATP. I suggest you get in touch with one of the ATPs to ask them about their experience with this kind of variation. I have a list of all of them and their contact details if you need.
I would really appreciate if you could give me a recommendation in LinkedIn 🙂 Thanks!
Have a great day,
Maria
That i can do not worries!!!
Dear Maria Mam ,
I am Neha Yadav , working as regulatory affairs officer , my company also want to registered product in Latam Countries starting with Mexico , i have gone through your above replies all are very helpful , but still can you give best sites for easy and clear understanding i mean how to start and what important points to be taken in consideration.
Thank you mam
Regards
Neha yadav
Dear Neha,
Thank you very much for your interest. Unfortunately, the best sources of information, including those from the official health authority, are in Spanish.
I did my best to summarize the most relevant information in this section of my website, and in the presentation that you can find on the home page.
If you know any other reputable and reliable website of info on RA in LatAm, please share it.
Have a great Labour’s Day!
Maria
Dear Maria,
Please provide the variation guidelines for Mexico.
Regards,
Ajay
Hi Maria,
Please provide the link of variation guideline for Mexico.
Regards,
Likhita
Dear Maria,
Would certain Vitamin and Dietary Supplement or OTC excipients still be considered “new molecules” and fall under the same regulations for food/drugs?
Dear Maria,
Please provide Drug Product ragistration procedure to enter into Maxico market, from pre submission application to approval; and timeline as per COFEPRIS for each step.
Dear Maria,
What is the stability studies requirement in Mexico. If i have long term stability data up to proposed shelf-life, is the data at accelerated condition required?
Regards,
Ajay
Dear Maria,
Hi! Please provide Mexico variation guidelines for Pharmaceuticals.
Regards,
Nagaraju
Wow, I’m glad I ran across your site. Thank you! We are looking to market a topical OTC homeopathic remedy in Mexico (export from U.S.). I don’t see a category for this. I saw in one of your replies that there is no abbreviated application, but is an entire application dossier required in this case?
Thankfully,
Wendy
is there trade mark registration is mandatory before registration of drug?
Provide me more details about Agreement for innovator……!!!
Hey Maria
Can i ask you a question..?
Where will i get in detailed information regarding all modules and forms for the same?
Regards ,
Chaitanya
Hi Maria,
I have gone through your all above comments and found really helpful. I have some concern as follows:
” we wants to register a product in Mexico, the product comes under ‘new drug’ (not present in Mexico) with an indication which is an orphan indication in Europe and USA; does not affect the pediatric population. The manufacturer is at Europe. The product dossier is going to be submitted soon in Europe for 1st time in world.”
1. Is this indication comes under orphan designation in Mexico and if yes will this have a special treatment in terms of application/fee/approval timeline or any thing.)
2. If we propose to file the same product in EU or USA will this application treated for Expedite review, or this is applicable only after approval in EU and USA.
Expecting a quick reply on the same.
Regards,
Sathya
Hello Maria Ma’am
I read your hole work . Really a great job.
But I want information in detail. So can you tell me sites or references where i will get all the information in detail ?
I also want photocopies of forms can I get that ?
hola Maria ma’am
I read your whole work.It seems to be very useful for me.
Really you did a great job.
But I want some information in detail. Like in case of Modules I want more information.
Can you give me some references so that I can get what I want ?
I also want photocopies of forms that need to be submitted as NDA in Mexico.
can you give me that?
Hi..
im M.Pharm Fresher just join the regulatory department in small consultancy. I need some information regarding to Module 1 CTD. Like the Certificates, Names, Time required for registration of drug, and all detailed information. plz help me..
Thanks in Advance
Dear Maria,
Would like to know your views on generic pharmaceuticals entering LATAM currently. Is it a possibility to work with distributors to market into LATAM? Also, does market authorisation by COFEPRIS cover Ecuador and Panama as well.
Thanks
Best Regards
Nicholas
hi maria,
need to know….if products registraion are expired and want to renew the registrations …is it mandatory to start from start?….and if i want the same products to be registered in new name or in new company name …what is the procedure?
Hi,
Are there requirements for encrypting data sent via e-mail to any of the Lat Am agencies?
If so, what are those requirements or where can they be found?
Thank you!
Christine
Dear Maria,
Could you please share your contact no. ?
I would like to know more information about the formularies in Mexico.
What are the advantages of getting product listed in formulary?
Is there any advantage in Private market for a product listed in formulary?
What is the process for getting product listed in formulary?
Hi,
What is the procedure to get a GMP certification for API manufactured outside Mexico? Is COFEPRIS inspection necessary in this case? If yes, how can we initiate this process?
Thanks,
ECPS
Dear Maria,
Do you know if a DMF (EU-ASMF) can be used for an application for biologicals in Mexico? And if yes, what information can be placed in the closed part (and what in the open part) of the DMF? Is there a Mexican guideline/regulation about DMFs? Thank you very much in advance.
Kind regards, Sandra
Dear Maria,
Is there a way to know how many new registrations have been made during a particular year in Mexico
Thanks,
Anita
Dear
I am from india and we want to register the product in below given country so pls
can you provide me the agent email id and contact details from central america such as
nicaragua,pananma,costa rica,Ecuador,Peru,chile,guatemala
as soos as
thanks
Hi Maria,
Could you please explain the types of testing that has to be performed on drugs manufactured abroad in order to export and sell in Mexico? Are these tests to be performed batch by batch, lot by lot, or just only during registration?
Hi Maria,
Could you please brief on the registartion renewal requirements in Mexico? Do we need to perform BE studies for renewal if initial approval without BE?
Could you please brief on Interchangeability requirements i.e Type A/B/C? For which products, we need to apply these?
Dear Maria
Is there any way wherein I can find the list of products,approved by COFEPRIS for Market authorisation.
Hello Maria,
Hope you are dong well. I had a question with medical device registration in Mexico. Given that we, a small US based device manufacturer, have the Certificate for Foreign Government from the USA (FDA), what would the need of a Free Sale Certificate from Non-US government be?
Hello Maria!!
Jalpa Joshi here. I wanted to know the registration fees for the additional strength dossier in Mexico. eg. If we have MA for 02 strengths for X product and we want to register the 3rd strength for the same product, how much fees we need to pay for registration application of this additional strength?
Your prompt response is highly appreciated.
Thanks.
Hi Maria,
I would like to know the requirements and the procedure for registration of Medical devices in Mexico. Can you please help?
Regards,
Vrushali
Hi: I wonder if anyone can tell me whether anyone can give me information about approval of antibiotics for multi-drug resistant bacteria in Mexico and Brazil? Is there any guidance regarding clinical data requirements ? Will clinical data of safety and efficacy that is satisfactory for approval by FDA and/or EMA be adequate for approval in Mexico or Brazil. Will there be a requirement for either PK or safety/efficacy data in local Mexican and Braizilian patients? Thanks you so much!
Anne
Hi Maria
I would like to know
how many sample requirement for drug product registration in mexico??
Thanx in advance……..
Dear Maria
Does the API GMP should be apostilled only in the certifying country for submission to Mexico.
Thanks….
Dear Bhavana,
yes the API GMP should be apostlled from certifying country.
Regards,
Raju