Mr.

Saini: This is the information you need to start the procedure of the
Sanitary Registration of Health. HERE, YO CAN SEE THE REQUIREMENTS.
SANITARY REGISTRATION? WHAT IS?

It is the authorization so that a product of sanitary interest can be manufactured,

imported, packed or ordered once all the technical and legal requirements are
fulfilled.

They are products of sanitary interest: food and beverages, medicines, cosmetics,
hygienic products, dangerous substances, devices and equipment for medical use,
natural products, laboratory reagents and others that are considered by the health
authority. These are classified as:

Risk A, or high risk; Risk B, or medium risk; and Risk C, or low risk. (See the
classification of products in annex 2).

➢ Who performs the procedure: The owner, through a legal professional.

➢ Where it is carried out: The records of medicines, cosmetics and personal

hygiene products can only be made in Tegucigalpa, in the General Directorate
of Surveillance of the regulatory framework, through the Department of
Surveillance of the Sanitary Regulatory Framework, located in the annex
building no. 1 of the Secretary of Health, in front of Farmacia Regis, avenida
Jerez.

Food products for human consumption must be registered with the Ministry of Health,
the Surveillance Department of the regulatory framework, the General Directorate for
Surveillance of the regulatory framework, the Metropolitan Region, the Fire
Department, Tegucigalpa and the Sanitary Regulation Regions of San Pedro Sula, La
Ceiba, Santa Barbara, Comayagua, Juticalpa and Choluteca.

Average time: 21 business days

Cost: Varies, depending on the type of product to be registered

The following documentation will be presented:
1. Application with the heading "Health registration requested", with the following
information.

2. Office to which it is addressed: in Tegucigalpa, General Directorate for Monitoring

the Regulatory Framework, and in the other municipalities, in the Departmental Health
Department Headquarters.

3. Name and general information of the owner or legal representative of the

establishment.

4. Reason or denomination of the company.

5. Exact address of the establishment, including telephone, fax and email.

6. Data and classification of the product: commercial name and generic name,
manufacturer, type of product, country of origin and manufacturing, and health license
number of the establishment that manufactures it.

7. Type of packaging and primary and secondary packaging.

8. Commercial form or presentation

9. Place and date of the request.

10. Signature of the applicant

The application must be adhered to:

1. Two labels / primary and secondary packaging or a copy of the project that contains
information according to the current technical labeling standard.

2. Product samples in quantity according to technical standard.

3. Letter of power granted to the legal professional, authenticated.

4. Two samples of the packaged product, as it will be marketed.

5. Payment receipt granted by the Ministry of Health for the right to register the
sanitary service and analysis service, which is the answer in the customer service
window of the Official Laboratory of the Pharmaceutical Chemical College of Honduras,
located in the Colonia Lara, Tegucigalpa
Recovery fees for services rendered according to the following tables:

TABLE I

SANITARY REGISTRY OF CHEMICAL, PHARMACEUTICAL, COSMETIC AND BIOLOGICAL

PRODUCTS:

No. DESCRIPTION RECOVERY FEE

1. Evaluate Pre - Registration (10$ USD)

2. Registration of Brand (75$ USD)

Products
3. Renewal of Brand Products (60$ USD)

4. Extemporaneous Brand (75$ USD)

Products Renewal
5. Registration of Generic (70$ USD)
Products
6. Renewal of Generic (50$ USD)
Products

7. Extemporaneous (70$ USD)

Renovation of Generic
Products
8. Change of Fund in the (30$ USD)
Sanitary Registry

9. Change of Form in the (10$ USD)

Sanitary Registry

10. Recognition of Sanitary (15$ USD)

Record Medication

* The cost of laboratory analysis is not included.

Pharmaceutical products, in addition to the above,
require:

1. Qualitative and quantitative complete formula, signed and sealed by the responsible
Pharmacist (original).

2. Commercial presentations

3. Product monograph

4. Phase III clinical studies of the product (for new molecules in the market)

5. Technical specifications of the product

6. Analytical method validated by the manufacturing laboratory, when the product is

not pharmacopical.

7. Document proving the commercial relationship between the owner and the
manufacturer of the products, when these are different.

8. Stability study, according to established norm.

9.Mandatory insert, or its project in products, when the required information is not in
the primary or secondary packaging, according to the current labeling standard.

10. Certificate of free sale, obtained at the Ministry of Industry and Commerce, at the
Directorate of Productive Sectors of the country of origin (FOOD), or certificate of
pharmaceutical product type World Health Organization (WHO). If this certificate is not
attached, it will be necessary to present the Certificate of Good Manufacturing
Practices, stating that the laboratory is subject to periodic inspections by the
corresponding regulatory body, with a validity no longer than 24 months of issue.
For cosmetic products, the requirements established in RTCA
71.01.35:

All documentation must be presented in Spanish / Spanish, official documents

written in a different language, must be presented with their respective official
translation.

For the registration or sanitary registration of cosmetic products, the States Parties
shall adopt the updated list of prohibited substances and restricted substances in the
consolidated text of the Official Publication Office of the European Communities and
the List issued by the United States. of America, having the least restrictive list
preeminent.

1. Application for registration or health registration.

2. Certificate of Good Manufacturing Practices or manufacturing authorization

document duly legalized, issued by the regulatory authority or competent authority
or authorized entity of the manufacturing country.

3. Power in favor of the legal representative. If the document is granted abroad, it

must be legalized.

5. Qualitative complete formula indicating the quantities of restricted substances,

issued by the manufacturer and endorsed with the signature and stamp of the
professional responsible for registration.

6. Finished product specifications extended by the manufacturing laboratory.

7. Original packaging or its readable projects. Photocopies are not accepted.

8. Proof of payment of right to registration process or sanitary registration, which

also includes health surveillance.

9. The valid documents that appear in the archives of the authority that performs the
registration for having been delivered previously should not be presented again, if it
is not enough to indicate where these documents are located or the related opinion
number. That document that must be issued by the same authority that performs
the registration or registration.
 LEGAL COSTS COSTS FOR PROCEDURE

• Registration and 650$ USD

Authorization of drug brands

• Certification of Free Sale

250$ USD

• Sanitary License 850$ USD

• LEGAL ADVICE AND REVISION OF 120$ USD

DOCUMENTS.

• Transport Mobilization and

50$ USD
others.

TOTAL:

ADMIN COSTS Costs

• proxy statement (Carta 25$ USD

Poder.)

• Medical analyzes. ----

GASTO ADMINISTRATIVO:

GASTO HONORARIOS
PROFESIONALES:

PAGO TOTAL:
 GASTO ADMINISTRATIVO:

GASTO HONORARIOS
PROFESIONALES:

PAGO TOTAL:

The duration of the procedure is 21 days or depends of the

cases. FOR THE PAYMENT OF BOTH ADMINISTRATIVE
EXPENSES AND PROFESSIONAL FEES, THEY CAN MAKE A
DEPOSIT TO THE BANK ACCOUNT OF THE BANK OF WESTERN
NUMBER 21-440-009838-8 on behalf of Abg. Gina Trejo OR
MAKE IT IN CASH.

For more information you can contact me :

CEL NUMBER 9532-9480 OR MY EMAIL ADDRESS

gtrejo9131@gmail.com