Regulatory Updates

Distribution date: 14 March 2017 | Final date for Comment: 13 May 2017

The notified draft Resolution establishes the national pharmacovigilance system for medicines and biological products for veterinary use.The text covers the following: Purpose; Scope; Definitions; General objective of the national pharmacovigilance system; Specific objectives of the national pharmacovigilance system; Components of the national pharmacovigilance system; Entities participating in the national pharmacovigilance system; Obligations of the ICA as regulatory authority; Obligations of veterinary medicine and biological product sales licence holders and importers; Obligations of reporters; Information sources for the national pharmacovigilance system; Information flow; Periodic safety report (IPS); Events to report; Report criteria; Causation analysis investigation; Causation categories; Criteria for inclusion in the various categories; Corrective actions; Post-registration studies; Communication and dissemination; Transitional provision; Penalties; and Period of validity.

Products Covered: Medicines and biological products for veterinary use.

Regulation Type: Regular notification

Distribution date: 09 March 2017

Products Covered: Petroleum products (headings 27.01 to 2901.10) ;

Regulation Type: Addendum to Regular Notification

Distribution date: 08 March 2017

Products Covered: Antifreeze

Regulation Type: Addendum to Regular Notification

Distribution date: 03 March 2017 | Final date for Comment: 02 May 2017

1. Amendment of standards for scope, application and limitation of Lactulose and Ferrous sulfate, dried. 2. Establishment of standards for specification, scope, application and limitation of Sodium dihydrogen citrate.

Products Covered: Food additives to be used in foods

Regulation Type: Regular notification

Distribution date: 27 February 2017 | Final date for Comment: 28 April 2017

<span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;"></span><span style="color:black;font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:Verdana, sans-serif;font-size:9pt;"></span></span><span style="color:black;font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:Verdana, sans-serif;font-size:9pt;">This Draft Uganda Standard </span></span><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">specifies requirements and methods of sampling and test for magnesium sulphate fertilizer</span><span style="color:black;font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">.</span></span></span><span style="font-size:x-small;font-face:Verdana;"><span style="color:black;font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;"></span></span></span>

Products Covered: Magnesium sulphate fertilizer.

Regulation Type: Regular notification

Distribution date: 27 February 2017 | Final date for Comment: 28 April 2017

<span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;"></span><span style="color:black;font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:Verdana, sans-serif;font-size:9pt;"></span></span><span style="color:black;font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:Verdana, sans-serif;font-size:9pt;">This Draft Uganda Standard </span></span><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">specifies requirements and methods of sampling and test for </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">inorganic foliar</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">fertilizers</span><span style="color:black;font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">.</span></span></span></span></span><span style="font-size:x-small;font-face:Verdana;"><span style="color:black;font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;"></span></span></span>

Products Covered: Inorganic foliar fertilizer.

Regulation Type: Regular notification

Distribution date: 27 February 2017 | Final date for Comment: 25 March 2017

The notified draft Ecuadorian Sanitary Technical Regulation covers the following: Purpose; Scope; Definitions; General considerations; Mandatory sanitary notification (NSO), procedure and amendments, recognition (mandatory sanitary notification procedure, amendments to mandatory sanitary notification, recognition of mandatory sanitary notification code); Circulation of samples of no commercial value; Certificate of free sale and export certificate; Operating permit; Donation of cosmetics, domestic hygiene products or absorbent personal hygiene products in the event of a health emergency; Good manufacturing practices (GMP); GMP certification procedure; Inspection service and GMP certification fees; Notification of changes to GMP certificate; GMP certificate; and Monitoring and inspection.

Products Covered: 3305.10.00.00

Regulation Type: Regular notification

Distribution date: 27 February 2017 | Final date for Comment: 28 April 2017

<span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;"></span><span style="color:black;font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:Verdana, sans-serif;font-size:9pt;">This Draft Uganda Standard </span></span><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">specifies requirements and methods of sampling and test for organic fertilizers</span><span style="color:black;font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">.</span></span></span>

Products Covered: Organic fertilizer.

Regulation Type: Regular notification

Distribution date: 27 February 2017 | Final date for Comment: 28 April 2017

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Veterinary drug: Melengestrol Acetate.

Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) - Dairy produce and birds' eggs (HS Codes: 04.01, 04.07 and 04.08) - Products of animal origin (HS Code: 05.04) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification

Distribution date: 22 February 2017 | Final date for Comment: 17 March 2017

<p style="margin:6pt 0cm;"><span lang="EN-GB">This Draft Resolution proposes the implantation of the National Medicine Control System (NMCS) and the mechanisms and procedures for medicine track and tracing, besides other measures<span>. </span></span></p><p style="margin:6pt 0cm;"><span lang="EN-GB">These mechanisms and procedures for </span><span lang="EN-GB">medicine track and<span> tracing is applicable throughout the national territory.</span></span><span><span lang="EN-GB" style="background:white;font-family:'Arial','sans-serif';">&nbsp;</span></span></p><p style="margin:6pt 0cm;"><span lang="EN-GB">The provisions of this </span><span lang="EN-GB">proposal<span> apply to all medicines registered at the Brazilian Health Regulatory Agency (ANVISA). It is not applicable to serum and vaccines that are part of the National Immunization Program; radiopharmaceuticals; non-prescription medicaments; medicines included on the Programs of medicines for free distribution and individualized delivery control of the Ministry of Health; specific medicines and phytomedicines; free samples.</span></span></p><p style="margin:6pt 0cm;"><span lang="EN-GB">Medicine track and tracing s<span>ystem establishes mechanisms and procedures that allow to recovery the medicine history, identify its current location and the last known destination.</span></span></p><p style="margin:6pt 0cm;"><span lang="EN-GB">The bidimensional bar code is the technology used to capture, store and comunicate events related to </span><span lang="EN-GB">medicine track and tracing on the NMCS and the DATAMIX is the adopted standard as established <span>&nbsp;</span>on ISO/IEC 16022:2006. The owner of the medicine marketing authorization is responsible for the generation and inclusion of the Datamix on the comercial package, including data of <span>&nbsp;</span>the Unique Medicine Identificiation (UMI) and other provisions established at RDC Nº 71 from 22 December 2009 (available at <a href="http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2009/res0071_22_12_2009.html">http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2009/res0071_22_12_2009.html</a>) and modified by the RDC Nº 26 from 16 June 2011 (available at http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2011/rdc0026_16_06_2011.pdf).</span></p><p style="margin:6pt 0cm;"><span lang="EN-GB">Every transport package, from expedition at the marketing authorization owner, should have a unique identification code that allows identify the UMI inside it.</span></p><p style="margin:6pt 0cm;"><span lang="EN-GB">Imported medicines may have the Datamix and serial code printed by the manufacture on the country of origin or by the owner of the authorization in Brazil.</span><span lang="EN-GB"> The option adopted should be informed to Anvisa at the process for the Import Licence. </span></p><p style="margin:6pt 0cm;"><span lang="EN-GB">Each member at the medicine supply chain should store and transmit electronically the data regarding the events of the medicine under its responsibility.</span></p><p style="margin:6pt 0cm;"><span lang="EN-GB">The technological specifications related to the NMCS procedures will be published as Normative Instruction before the end of the fourth month after the date of publishing of this technical regulation.</span></p><p style="margin:6pt 0cm;"><span lang="EN-GB">This proposal revokes the Resolution RDC Nº 54 from 10 December 2013 (available at </span><span lang="EN-GB"><a href="http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2013/rdc0054_10_12_2013.pdf"><span>http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2013/rdc0054_10_12_2013.pdf</span></a><span>) and the RDC Nº 114 from 29 September 2016 (available at </span><a href="http://portal.anvisa.gov.br/documents/10181/2718376/RDC_114_2016.pdf/823dbdb9-c11f-45fa-b313-220426e75fb0"><span>http://portal.anvisa.gov.br/documents/10181/2718376/RDC_114_2016.pdf/823dbdb9-c11f-45fa-b313-220426e75fb0</span></a><span>)</span></span></p>

Products Covered: Medicines

Regulation Type: Regular notification