CleverDigital, Author at Dc Blue https://www.dcblueconsulting.com/en/author/cleverdigital/ Consulting Fri, 20 May 2022 16:06:54 +0000 en-GB hourly 1 https://wordpress.org/?v=5.9.10 https://www.dcblueconsulting.com/wp-content/uploads/2022/06/cropped-original-32x32.jpg CleverDigital, Author at Dc Blue https://www.dcblueconsulting.com/en/author/cleverdigital/ 32 32 Update of the list of reference products for demonstration of biosimilarity https://www.dcblueconsulting.com/en/2022/05/13/update-of-the-list-of-reference-products-for-demonstration-of-biosimilarity/ https://www.dcblueconsulting.com/en/2022/05/13/update-of-the-list-of-reference-products-for-demonstration-of-biosimilarity/#respond Fri, 13 May 2022 14:26:27 +0000 https://entornoweb.cl/cdigital/dcblueconsulting/?p=2339 On November 16, 2021, the Ministry of Health has issued the Exempt Decree No. 62 that modifies the exempt decree No. 945 that approves the technical guideline No. 170 on health registration of biotechnological products derived from recombinant DNA techniques. The most relevant changes included in Decree No. 62 are the following: Update of the …

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On November 16, 2021, the Ministry of Health has issued the Exempt Decree No. 62 that modifies the exempt decree No. 945 that approves the technical guideline No. 170 on health registration of biotechnological products derived from recombinant DNA techniques.

The most relevant changes included in Decree No. 62 are the following:

  • Update of the list in numeral X «Active Ingredients and their respective presentations with respect to which abbreviation of clinical studies may be admitted in the sanitary registration process» and «List of Reference Biotechnological Products».
  • In addition to what is referred to in the list of numeral X of Technical guideline No. 170, reference biotechnological products will be considered those that are determined as such by the Food and Drugs Administration of the United States of America, the European Medicines Agency » of the European Union and the «Pharmaceutical and Medical Devices
    Agency» of Japan.

Source: www.diarioficial.cl

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]]> https://www.dcblueconsulting.com/en/2022/05/13/update-of-the-list-of-reference-products-for-demonstration-of-biosimilarity/feed/ 0 Alignment in relation to the condition of sale and graphic labeling of medicines https://www.dcblueconsulting.com/en/2022/05/13/alignment-in-relation-to-the-condition-of-sale-and-graphic-labeling-of-medicines/ https://www.dcblueconsulting.com/en/2022/05/13/alignment-in-relation-to-the-condition-of-sale-and-graphic-labeling-of-medicines/#respond Fri, 13 May 2022 14:24:33 +0000 https://entornoweb.cl/cdigital/dcblueconsulting/?p=2332 Exempt Resolution N°395 On March 8, 2022, the Institute of Public Health has issued exempt resolution No. 395, instructing the Department of the National Medicines Agency, ANAMED, to consider rules regarding the graphic labeling of medicines.  Avoid legends related to the type of establishment that can market the product.  The approved sales conditions must be …

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Exempt Resolution N°395

On March 8, 2022, the Institute of Public Health has issued exempt resolution No. 395, instructing the Department of the National Medicines Agency, ANAMED, to consider rules regarding the graphic labeling of medicines.

  1.  Avoid legends related to the type of establishment that can market the product.
  2.  The approved sales conditions must be in accordance with article 32 of the Decree 466:
    a. Direct sale
    b. Sale under simple prescription
    c. Sale under retained prescription
    d. sale under prescription check
  3. Products registered prior resolution No. 395 must be updated at the time of granting the renewal of the corresponding sanitary license.

Source: www.ispch.cl

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