LABELING OF MEDICINES

Federal Commission for Protection from Sanitary Risks- COFEPRIS -

Ministry of HealthMexico

Index• Aplicable regulatory framework.• Requirements for labeling of medicines.• Medicines traceability. • Medicine ingredients, consequences of bad ingredients or

changes in formulation.• What is a substandard medicine?• Seizure of medicines• Importance of GMP

Aplicable regulatory framework• General Law of Health.• Regulation for Medical products.• NOM-059-SSA1-2015. Good Manufacturing Practices of

medicines. • NOM-072-SSA1-2012. Labeling of medicines and herbal

products. • Supplement for establishments dedicated to selling and

supply of medicines and other medical products of the United Mexican States Pharmacopeia.

Labeling of medicinesLabel, any tag, label, mark or graphic image that has been written, printed,stenciled, marked, embossed or marked in hole, graven, adhered, or sealed in anymaterial susceptible to contain the medicine or herbal product including thecontainer itself.

The texts in the label or instructions of the medicines, contain the sanitary andcommercial information that identifies the medicine to establish with precision itsidentification in the market and to guide and warn the user about the adequate andsafe consumption of medical products.

It must be authorized by the Ministry of Health by assigning an alphanumeric code,during the approval process of the sanitary authorization or when the conditions ofregistration are modified.

(NOM-072-SSA1-2012. Labeling of medicines and herbal products. )

The labels must indicate:• Generic denomination;• Distinctive denomination; in the case of generic medicines the inclusion is

optional; • Declaration of active ingredients; • The identification data and address of the manufacturer and distributor when

applicable; • Preservation instructions; • Date of expiry;• Batch number; • Dose and way of administration; • Preventive legends, including the risk of use during pregnancy; • Warning legends; • When the information is in other languages, it must appeared in Spanish as well,

at least in the same size and proportion.

Traceability of medicinesThe capacity to rebuild history, location of an element or activity by identification records.(NOM-059-SSA1-2015, Good manufacturing practices of medicines).

For an adequate traceability it is required:• A validated computer system (manufacturer and warehouses).• Records of entries of medicines that allow for the tracing of its origin through the identification of its

denomination, batch number and presentation, congruent with the system First Expired-First out (FEFO) or Firstin-First out (FIFO)

• Medicine stock control in compliance with the Standardized Operational Procedures.• Invoices issued by the supplier or documents that evidence the legal posession of the medicines, including

donations and warehouses movements or deposits withing the same institution or company, that contain:quantity, generic denomination, distinctive denomination (when applicable), presentation and batch number.

• Books or an authorized control system for narcotic or pychotropic medicines clasified under fractions I,II, and III.• Antibiotic control in drug stores: requierements for the prescription supply and control records (in and out)

(Agreement on guidelines for selling and supply of antibiotics)• For ingredients the analytical certificate is required.

Medicine ingredients• All medicines must have a sanitary authorization (registry).• Any change in the medicine formulation must be notified to the sanitary authority.• The manufacturing of a medicine must be performed by the conditions descibed in the sanitary

authorization in which it is detailed the concentration of ingredients, additives and excipients.

Any modification of the authorized formula or use of bad quality ingredients generates:- Adulterated medicines,- Altered medicines,- Contaminated medicines,- Falsified medicines.

Also the non-compliance with Good Manufacturing Practices can originate medicines with no guarantee ontheir quality, eficacy or security.

The above will motivate the seizure of the product, product recall and/or suspension of activities.

Low quality or substandard medicine:• Medical products of substandard quality also denominated “out of specification” products, are authorized products

that do not meet either quality standards or their specifications, or both.OMS, Substandard and Falsified (SF) Medical Products http://www.who.int/es/news-room/fact-sheets/detail/substandard-and-falsified-medical-products

It is estimated that 10% of medical products in low and medium income countries, are substandard quality orfalsified.

• Medical products of substandard quality and/or (illegal) falsified usually are manufactured in poor conditions,without the adequate hygiene and with participation of non-qualified personnel. These products can containunknown impurities or even be contaminated with bacteria.

• This kind of products are hard to detect and may not cause adverse or immediate reactions, even though theyfrequently result ineffective treatments for the diseases they are indicated leading to serious health consequencesand even death.

• Mexico ranks sixth worldwide in counterfeit medicines.• Illegal comerce and falsification generate earnings to organized crime above 6 million dolars anually.• This illegal markets are found mainly in informal sale points (tianguis), pseudo-pharmacies, street vendors and

even in web pages of non confirmed origin.•

Seizure of medicines (Sanitary surveillance of medicines)Year Special

operationsSeizure (Tons) Location

2009 7 91 El santuario

2010 17 2.5

2011 19 93.5 Guanajuato, Jalisco, Puebla, D.F.

2012 32 31Baja California, Baja California Sur, Hidalgo, Jalisco, D.F., Aguascalientes, Nayarit, Oaxaca, Quintana Roo, Chiapas,

Guanajuato, Veracruz, Durango, Coahuila.

2013 15

173 tons14 tons of raw material12 tons of packing material38,994,512 pieces of packing material 8,824 labels

Guerrero, Jalisco, D.F., Estado de México, Quintana Roo, Chihuahua, Durango, Puebla, Hidalgo, Baja California Norte.

2014 13 5.8 Jalisco, Estado de México, DF, Puebla.

2015 39 66 tons55 Tons of raw material Jalisco, Estado de México, DF

2016 2417.81 tons12.87Tons of raw material

Ciudad de México, Morelos, Jalisco, Chiapas, Estado de México, Veracruz, Puebla, Nuevo Leon y Guanajuato

2017 30 60 TonsVeracruz, Michoacán , Nayarit ,Chiapas, Guanajuato, Nuevo

Leon ,Jalisco y Ciudad de México

2018 5 8.8 TonsVeracruz, Michoacán , Nayarit ,Chiapas, Guanajuato, Nuevo

Leon ,Jalisco y Ciudad de México

10

SANITARY SURVEILLIANCE OF MEDICINES

Classification of seizured medicines 2010-2018

Importance of Good Manufacturing Practices

Good Manufacturing Practices are an element to guarantee quality bypharmaceutical companies, in order to ensure a uniform and controlledmanufacturing in compliance with the standards for its use and according to theconditions requested for its marketing.

The Good Manufacturing Practices certificate, is the document that accredits therecognition of Good Manufacturing Practices in medicines which ensure theavailability of medical products, that are safe and effective.

Within the process of conditioning of medicines it is important to guarantee thecorrect labeling in order to provide the population with the information aboutmanufacturing, storage and use conditions to avoid expired, contaminated, altered(e.g. changes in formulation to cover bad practices), adulterated products, orproducts in bad conditions.

GRACIAS / THANK YOU / cпасибоÁLVARO ISRAEL PÉREZ VEGA

COMMISSIONER OF SANITARY ENFORCEMENTaiperez@cofepris.gob.mx

+52 (55) 5080 5200 ext.1391