Showing posts with label Costa Rica. Show all posts
Showing posts with label Costa Rica. Show all posts

7 Jan 2017

Ministry of Health promotes use of Digital Recipe from May 2017


January 3, 2017. The Digital Recipe System will be available to health professionals from May this year for the issuance and dispatch of digital prescriptions for drugs classified as narcotic and psychotropic (known as "green recipe" and " Blue recipe ").

Ministry of Health promotes use of Digital Recipe from May 2017
It facilitates the issuance of recipes and the dispatch of the same.
Eliminates unnecessary paperwork and the use of paper
Improves control of the issuance and dispatch of addictive drug prescriptions
The digital recipe will be mandatory for the issuance of prescriptions of narcotic and psychotropic drugs

January 3, 2017. The Digital Recipe System will be available to health professionals from May this year for the issuance and dispatch of digital prescriptions for drugs classified as narcotic and psychotropic (known as "green recipe" and " Blue recipe "). This platform will allow the Ministry of Health to improve controls in the prescription and dispatch of these drugs and health professionals, pharmacies and drugstores to automate monitoring and allow the efficient dispatch of prescriptions.


For users, the digital prescription offers a number of advantages: there is no risk of losing the prescription and allows a direct interaction between the patient and the doctor.

The implementation of the Digital Recipe System is regulated by Executive Decree No. 39984-S of November 9, 2016: "Regulation for the Use and Operation of the Automated System of Digital Recipe for Psychotropic and Narcotic Drugs," promulgated by the Ministry of Health.

The decree modifies the way in which psychotropic and narcotic drugs are registered, notified and monitored. This means that from now on you will stop using prescription paper and you will be able to access your medicines just by presenting your identity card to a Health establishment.

The Ministry of Health communicates to health professionals (dentists, pharmacists and doctors), pharmacies, drugstores, laboratories and medical centers that must be prepared for the use of the system. The Ministry of Health in conjunction with Digital Government will be carrying out the following actions:
for more information: 


Costa Rica: Ministerio de Salud de Costa Rica

Ministerio de Salud de Costa Rica


https://www.ministeriodesalud.go.cr/

Costa Rica’s Registered Drug database is very well managed by the Costa Rica’s Drug Regulatory Authority (Ministerio de Salud de Costa Rica).
Registered database is updated on monthly basis within a year and provides downloadable xls sheet for the following categories.
Registered product search is also available in the website year vise in the database.

· Foods
· Cosmetics
· Biomedical equipment and material
· Medicines
· Pesticides
· Natural products
· Hygiene products
· Hazardous chemicals
· Tattoo Inks

Pricing: is not available in the online database.

Languages: Spanish

Database xls sheet provide the detailed information of the registered product e.g.

  • COUNTRY
  • CONSECUTIVE
  • EXPIRATION
  • NAME REMARKS
  • MANUFACTURER SESSION
  • ARTICLE
  • PRODUCT TYPE
  • LABORATORIO HOLDER
Medicines section also provides the following information on the same page.






Medicines

Legislation
· Law No. 5395. General Health Law
· Decree 28466-S. Regulation of registration, control, importation and advertising of medicines
· See more regulation for medicines >>

Products registered

· List of registered drugs

Applications

· Request for the return of money (Not applicable for registrations in the System Register it).
· Instructions for completing the application form for the return of money

Medication registration

· Applications
o Application for registration of medicines
o Application for registration of biological medicines
o Radiopharmaceutical registration application form
o Application form for prior review of advertising of products of health interest

· Documents
o Receipt by deposit for paperwork
o Requirements for registration of medicines
o Press release DRPIS-UR-484-2015. Register of Medicinal Gases
o Press release DRPIS-UR-097-2015. Clarification on radiopharmaceutical registration
o Proof of submission of medication dossiers
o Interpretation of the power of legal representative and certification of the contract of manufacture of third parties for the sanitary registration of medicines
o Communiqué on "Procedure for the application of the single prevention"
o Circular DRPIS-1554-12-2013. Interested in advertising Products of Health Interest
o Press Release DAC-400-2012. Bioequivalence Study Requirements and Comparative Dissolution Profile Studies
o Communiqué DAC-UPS-004-C-2012. Re-establishment of the requirement of bioequivalence studies (207.5 kB)
o Circular DRC-913-09-08. Stability Study
o Circular DRC-911-09-08. Change in state control procedure
o Circular DRC-785-07-08. Certification of bioequivalence
o Circular DRC-106-01-07. Omission of photocopies of bibliographical citations that support the monograph
o Circular DRC-067-01-07. Users of the System of Registration of Medicines, Cosmetics, Natural Products, Food and Biomedical Equipment and Material

· Guides
o Validation guide for analytical methods
o Medication registration application compliance guide
o Medication Registration Request Filing Guide
o Guide for the technical evaluation of drug labeling
o Technical assessment guide for stability studies
o Guide for the technical evaluation of monographs
o Technical evaluation guide of clinical studies for the sanitary registration of medicines
o Guide to the technical evaluation of the qualitative quantitative formula for the sanitary registration of medicines

Post-medication changes

· Applications
o Request for post-registration changes to medicines

· Guides
o Guide to filling out the request for post-registration drug changes
o Guide to compliance with the request for post-registration changes to medicines

Renewal of medicines

· Applications
o Request for drug renewal