• Procedures for sanitary registry in Colombia.
• Sanitary Registry Application and Procedures.
  
• Control and Surveillance of Administrative Procedures.
  
• Continuous information to customer about the status of procedures.
  
• Notice of renewal of registry.
  
• Engineer of Chemist assistance for the reviewing of the technique documents for the Sanitary Registrations.
• Presentation of legal remedies and actions aiming at defending the rights of customer.

LAWS - Sanitary Registry of Cosmetics in Colombia currently applicable in Colombia. (Decree 219 dated 30 January 1998).

DEFINITION

• The term cosmetics as used herein means any substance or formulation of topical application used on the several parts of the human body skin: dermis, pilosebaceous and capillary systems, nails, lips, and external genital organs or teeth and mouth mucosa, with the purpose of cleaning them, aromatizing them, change the presentation thereof, and protect them or keep them in good conditions and also to prevent or correct the body pains.

SANITARY REGISTRY REQUIREMENT

• All cosmetic products require for their production, processing, packing, expanded packing, imports, exports or trading in Colombia, INVIMA issued sanitary registry.

CLASSIFICATION OF COSMETIC PRODUCTS

• Cosmetic products can be classified into:

  (a) Cosmetics for children
  (b) Cosmetics for eyes
  (c) Cosmetics for skin
  (d) Cosmetics for lips
  (e) Cosmetics for body cleaning and toilette
  (f) Deodorants and antitranspirants
  (g) Capillary cosmetics
  (h) Cosmetics for nails
  (i) Cosmetics for perfumery
  (j) Products for mouth and teeth hygiene
  (k) Products for and after shaving
  (l) Products for tanning, sun protection and self tanners
  (m) Peelings
  (n) Skin bleaching products

THERAPEUTICAL ACTIVITY PRODUCTS

• Cosmetic products featuring therapeutical activity are deemed as medicaments and are subject to medicament regulations.

MODIFICATION OF COSMETICS SANITARY REGISTRIES

• Modifications to Sanitary Registries shall be authorized by INVIMA.

VALIDITY

• Sanitary Registries of cosmetics shall be valid for a five year period from the granting date.

RENEWAL

• They shall be renewed for equal terms, upon the request from the interested party, no later than the expiration date of registry.

REVISION, CANCELLATION AND QUALITY CONTROL

• INVIMA or a delegated entity will carry out said revisions, cancellations and QCs.

IMPORTS OF COSMETICS

• Cosmetics introduced into Colombia must have INVIMA sanitary register. Is deemed as fraudulent product, the one without any INVIMA Sanitary Register and the manufacturer or importer thereof shall be held liable for the sanitation measures and INVIMA actions, including the notice, seizure of products, fines, etc.

RIGHTS CONFERRED

• The right to import and sell, import, manufacture and sell, import, semi-manufacture and sell, or import, fill and sell cosmetic products within the Colombian territory.

REGISTRY OR SANITARY RECORD OF COSMETICS WITHIN THE ANDEAN GROUP (Decision 412 of July 14, 1997)

• This is an agreement signed by Colombia.
• GRANTING COUNTRIES: Colombia, Bolivia, Peru, Ecuador and Venezuela.

PRODUCTION OF COSMETICS

• All products traded in the Andean Region are t be manufactured in compliance with:
  Provisions in the good practices of cosmetic manufacture and international listings on ingredients which can be incorporated or not into the cosmetics, and restrictions or conditions of use, the following listings of usage are recognized as follows:

- UNITED STATES FOOD AND DRUG ADMINISTRATION (FAA).

- COSMETICS TOILETRY AND FRAGRANCE ASSOCIATION (CTFA).

- Directives from the EUROPEAN UNION.

NEEDS OF SANITARY RISK OR SANITARY REGISTRY OF EACH OF THE MEMBER COUNTRIES.

• Cosmetic products require, for the trading thereof, the sanitary registry in the Member Country where they eill be commercialized.

SAMPLES OF COSMETIC PRODUCTS

• Samples of cosmetics made by a member country does not require any sanitary registry within the recipient country, as long as they are provided with a sanitary registry or sanitary record in the country of origin.

SAMPLE OF IMPORTED COSMETIC PRODUCTS OF COUNTRIES WHICH ARE NOT MEMBERS OF THE SUBREGION

• The free trade certificate is required as issued by the national authorized entity

DURATION OF SANITARY REGISTRY

• Member countries can establish the time of validity for sanitary registries, but it cannot be less than five (5) years.

RIGHTS GRANTED (brief procedure)

• Right that the member country wherein the sanitary registry of the cosmetic product is requested issues the sanitary registry within twenty (20) working fays after the submission of all the necessary documents.
• If the registry is not issued within the above period is deemed as approved.

THERE IS NO ANDEAN COSMETIC REGISTRY

• For purposes of trading, a cosmetic product in any of the Member Countries the sanitary registry of each will be required.

LAWS- SANITARY REGISTRY FOR PRODUCTS LISTED APPLICABLE IN COLOMBIA (DECREE 2092 OF JULY 1986)

DENTAL APPLICATION MATERIALS

DEFINITION

• The expression Dental Use Materials as used herein refers to those dentistry used materials either temporary or permanent for the prevention, amelioration, restoration, correction or modification of altered tissues, or for the replacement of organs lost in the mouth cavity, as well as those materials necessary to develop the relevant techniques at the prosthesis or dental mechanics laboratories.

THE FOLLOWING MATERIALS REQUIRE A SANITARY REGISTRY:

• Materials for modeling, such as the following:

- Asbestos in rolls; dental application waxes; coatings for dental prosthesis laboraories; types I, II, III, and IV dental gypsum.

• Impression materials such as:

- Dental use cements; Zinc oxide paste with/without eugenol; modeling compounds (i.e. gidiva) of high, medium and low casting; mercaptans; silicones; alginates; reversible and irreversible hydrocolloids; materials for temporary and permanent restorations; plastic materials for obturations; metal alloys for obturations; alloys of precious metals and the like for dental colanders; tri-distillate mercury; materials for radicular conducts obturations; gutta-percha for dental applications.

• Materials for denturessuch as:

- Chrome cobalt alloysfor dental colanders; polymers for dentures base; auto cured resins.

The dental use products having some specific pharmacological action are registered as medicaments.

MODIFICATION OF A SANITARY REGISTRY

• Any change or modification of a registry shall be authorized by the INVIMA. For dental use materials the following can be requested:

  Change of trademark name
  Change, modification or addition of indications. Contraindications and use of the product
  Change of laboratory or manufacturer
  Change of holder
  Change of the sanitary registry holder
  Change of excipients, preservatives, dyes, or correctives
  Non substantial changes in the products active principles

VALIDITY

• Dental products sanitary registries are valid for 10 years from the effective date of the resolution whereby the sanitary registry has been granted.

RENEWAL

• They shall be renewed for equal periods upon the interested person request. The renewal request of the registry shall be filed within 6 to 12 months at least before the expiration date thereof. If the sanitary registry is due or if the renewal request is abandoned, then the relevant product cannot be imported or manufactured in Colombia. If there are stocks available, the interested party is given a six month term to use said stock. After 6 months, the stocks will be used up.
  REVISION, CANCELLATION AND QUALITY CONTROL
• INVIMA or the delegated entity will carry out the Revision, Cancellation or Quality Control functions.

SANITARY REGISTRY REQUIREMENT FOR IMPORTING DENTAL PRODUCTS

• Dental products can be imported only if they have a sanitary registry in Colombia. The dental product brought into Colombia without the sanitary registry are deemed as fraudulent products and the manufacturer or importer thereof shall be liable for the safety sanitary measures and penalties imposed by INVIMA, including a warning, seizure of products, fines, etc.

RIGHTS CONFERRED

• The right to manufacture, sale, imports and sale of dental use materials and products.

EQUIPMENT USED FOR THE APPLICATION OF MEDICAMENTS AND THE LIKE

LAWS - Sanitary Reistry for Equipment used for the application of medicaments and the like (Decree 2092, 1986)

DEFINITION

• The expression equipment for medication administration as used herein refer to those used for the purpose of providing human beings with medicaments.

THE FOLLOWING PRODUCTS REQUIRE A SANITARY REGISTRY

• Disposable syringes
• Equipment for venipuncture
• Equipment for dialysis
• Blood transfusion equipment
• Pericranial equipment
• Catheters
• Tubes

VALIDITY

• Sanitary registries of equipment used for the application of medicaments are valid for ten (10) years from the effective date of the relevant resolution.

REVISION, CANCELLATION AND QUALITY CONTROL

• INVIMA or a delegated authority will affect the revision, cancellation and QC.

IMPORTING OF EQUIPMENT USED FOR THE APPLICATION OF MEDICAMENTS AND THE LIKE

• Importing of equipment used for the application of medicaments and the like can be imported only if they have a sanitary registry in Colombia. The equipment used for the application of medicaments and the like brought into Colombia without the sanitary registry are deemed as fraudulent products and the manufacturer or importer thereof shall be liable for the safety sanitary measures and penalties imposed by INVIMA, including a warning, seizure of products, fines, etc.

RIGHTS CONFERRED

• The right to manufacture, sale, or imports and sale of equipment used for the application of medicaments.
• GAUZE, COTTON, PLASTERED BANDAGES, ADHESIVE TAPE, AND DRESSINGS
  Provisions relevant to medicaments application devices and equipment will be used herein.

LAWS - SANITARY REGISTRY OF MEDICAMENTS APPLICABLE IN COLOMBIA. (Decree No. 677 dated April 26, 1995)

DEFINITION

• The term medicament as used herein refers to the pharmaceutical preparation developed from active principles with auxiliary substances or without, which has been presented under pharmaceutical form which is used for the prevention, relief, diagnosis, treatment, healing or rehabilitation of the disease.

NEED OF A SANITARY REGISTRY

• All medicaments requires for the production, trading, imports, exports, packing, processing and selling thereof, the INVIMA issued sanitary registry.

CLASSIFICATION OF MEDICAMENTS.

NEW MEDICAMENTS.

• These are the medicaments whose active principle has not been included in the pharmaceutical standards manual, or the active principle which however included therein, corresponds to new associations or fixed dosages, or new indications, or new pharmaceutical forms, modifications implying changes of the administration routes, or in the trading conditions thereof.

MEDICAMENTS INCLUDED IN THE PHARMACEUTICAL STANDARDS

VALIDITY

• Sanitary Registries of medicaments will be valid for ten (10) years and will be renewed for equal time spans upon the request of the interested party.

RENEWAL

• For purposes of the renewal of medicaments sanitary registry, the procedure will be as follows:

- The pharmaceutical or technical assessment shall be applied for from INVIMA within the year before the expiration of the sanitary registry.

- The sanitary registry application shall be filed before INVIMA within at least three (3) months before the expiration of the sanitary registry

MODIFICATION OF MEDICAMENTS SANITARY REGISTRIES

• Modification of medicaments implying substantial modification of their composition shall be assessed by INVIMA upon the concept from the Pharmaceutical Products Revision Committee.
  Changes of excipients not changing the pharmacokinetics of the product, changes in the manufacture process, labels, packings and container changes, changes in the manufacture when the capacity thereof has been previously established, changes in the registry mode, changes in the product holder, changes of product trade name and change of business presentations shall be duly authorized by INVIMA.

REVISION, CANCELLATION AND QUALITY CONTROL

• To be effected by INVIMA or a delegated entity

MEDICAMENTS IMPORTS

• Medicaments having sanitary registries in Colombia are the only medicaments which can be imported into Colombia. Medicaments brought into Colombia without the applicable sanitary registry are deemed as fraudulent and the manufacturer or importer thereof shall be liable for the relevant Safety Measures and penalties established by INVIMA including the warnings, seizure of products, penalties, and the like.

SANITARY REGISTRY OR INSCRIPTION OF
MEDICAMENTS WITHIN THE ANDEAN GROUP

• Decision 418 of the Cartagena Agreement dated July 31, 1997 effective as of January 1, 1998.
• SIGNING COUNTRIES. Colombia, Bolivia, Peru, Ecuador, Colombia and Venezuela.
  
• The sanitary registry or sanitary inscription are required for the trading and selling of medicaments in each of the member countries.

RIGHTS CONFERRED

• The right to have the member country wherein the medicament sanitary registry is applied for, issue the sanitary registry or inscription within thirty (30) business days after the filing of all the necessary documents.
  The right to approval if the sanitary registry or inscription is not issued within the above provided term, holding the Colombian authorities liable for granting the relevant certification.

THE NON EXISTENCE OF THE ANDEAN MEDICAMENT REGISTRY

• In order to trade with a medicament in any of the Member Countries it is necessary to be provided with the sanitary registry in each of the member countries.

LAWS - SANITARY REGISTRY OF FOODS IN COLOMBIA (DECREE 3075 DATED DECEMBER 23, 1997)

DEFINITION

• The term “food” as used herein refers to a natural or artificial, manufactured or not manufactured product, which when ingested affords the human body the necessary nutrients and energy for the development of biological processes. Non alcoholic beverages and substances to seasoning some foods known as species are also included therein.

FOODS POSING A HIGHER PUBLIC HEALTH RISK

• Meat, meat by products and derivatives thereof
• Milk and milk derivatives
• Fishing products and derivatives thereof
• Egg based prepared products
• Low acidity foods packed in tight sealed packages
• Animal origin foods or edible prepared products, ready to use
• Bottled water
• Food for children

SANITARY REGISTRY NEEDS

• Foods intended to human consumption require for the manufacture, packing or imports thereof, the INVIMA issued sanitary registry.

FOODS DIRECTLY RELEASED TO CONSUMERS UNDER SOME SPECIFIC TRADE NAME, NOT REQUIRING SANITARY REGISTRY

• Natural foods which are not subject to any transformation process including grains, fruits, orchards, fresh vegetables, bee honey, and other agricultural staples.
  Raw animal origin foods either refrigerated or frozen, not subject to any transformation process.
  Raw material foods either manufactured in Colombia or imported for the exclusive use of industry and the gastronomy sector for the preparation of nutrients and foods.

SANITARY REGISTRY MODIFICATION

• Modification of sanitary registries for edible products shall be authorized by INVIMA.

VALIDITY OF FOODS SANITARY REGISTRY

• Foods sanitary registry will be valid for ten (10) years from the issuance date thereof.

SANITARY REGISTRY RENEWAL

• The sanitary registry will be renewed upon the request of the interested party not later than the sanitary registry date of expiration.

REVISION, CANCELLATION AND QUALITY CONTROL

• INVIMA or the authorized entity will accomplish with this work.

IMPORTS OF FOODS

• Foods imported into Colombia shall require the sanitary registry prior to the imports. Foods imported with no sanitary registry will be classed as forged commodities and the manufacturer or importer thereof shall be held liable for the sanitary and safety measures as well as for the penalties imposed by INVIMA including warnings, seizure of the commodities, or items, suspension or cancellation of the sanitary registry, etc.

LAWS - SANITARY REGISTRY OF CLEANING PRODUCTS FOR USE IN COLOMBIA (DECREE 1545 DATED AUGUST 4, 1998)

DEFINITION - HOME CLEANING PRODUCTS

• This group comprises the products which are mainly intended to freshen the environment, remove dirt and encourage the proper care of utensils, objects, clothes, or physical spaces which will subsequently be in contact with human beings.

DEFINITION - HYGIENE PRODUCTS

• This group comprises products having a proven disinfectant action, which products may or not meet the conditions of cleaning.

CLASSIFICATION OF PRODUCTS

• The following products are deemed as cleaning, and hygiene for home use.
  • Non cosmetic detergent soaps
  • Dish washing soaps
  • Smoothers and products for the pre laundry and pre ironing of clothes
  • Fresheners
  • Bleachers and stain removers
  • Home use disinfectants
  • Cleaners
  • Absorbent products for personal hygiene (tissues, disposable diapers,tampons, protectors for breast nourishing, damp clothes, etc)
• Raw materials and chemical products bearing in their labels directions for use including cleaning; hygiene products for home use requiring the INVIMA issued sanitary registry.

SANITARY REGISTRY REQUIREMENT

• All and any cleaning, hygiene product for home use will require for its production, processing, packing, sale, imports, exports and trading the sanitary registry issued by INVIMA.

SANITARY REGISTRY MODIFICATIONS

• Modifications of sanitary registry of cleaning and hygiene products shall be authorized by INVIMA.
• Modifications in the basic composition of cleaning and hygiene products of domestic use will require a new sanitary registry.
• There can exist modification to products of hygiene and cleaning for domestic use in dealing with secondary components, the name of brand and manufacturer name as well.

SANITARY REGISTRY VALIDITY

• Validity is five (5) years

RENEWAL

• They are renewed by equal terms, upon the request from the interested party before the expiration of said periods.

REVISION, CANCELLATION AND QUALTY CONTROL

• As done by INVIMA or the authorized entity.

CLEANING, HYGIENE PRODUCTS IMPORT

• Cleaning and hygiene products imported into the country require an INVIMA issued sanitary registry.
• Products imported into the country without a sanitary registry are considered as fraudulent products and the manufacturer or importer thereof shall be liable for the applicable sanitary measures of safety and penalties imposed by INVIMA such as warnings, penalties, seizure, etc.

JUDICIAL AND ADMINISTRATIVE ACTIONS

• Remedies before the Administration, action of cancellation of registry, action of voidance, disloyal competition trial, process of prohibition of usage, trial of precautionary measures, administrative contentious claims, criminal actions in defense of industrial property and actions to pertinent divisions.

AGREEMENTS

• Licensing agreements, royalties, know how, software, distribution, dealership and others.