Regulatory Updates
Proyecto de Reglamento Técnico Ecuatoriano PRTE INEN 088 "Agentes de Tensión Superficial" (Draft Technical Regulation of the Ecuadorian Standardization Institute (PRTE INEN) No. 088: "Surface tension agents") (6 pages, in Spanish) ;
Distribution date: 14 November 2013 | Final date for Comment: 13 January 2014
The notified draft Technical Regulation covers the following: Purpose; Scope; Definitions; General conditions; Requirements; Labelling requirements; Sampling; Conformity assessment tests; Reference documents; Conformity assessment procedure; Monitoring and inspection authority; Penalty regime; Liability of conformity assessment bodies; and Review and updating. ; ;
Products Covered: 34.01.11.00, 34.01.19.00, 34.01.19.10, 34.01.19.90, 34.01.20.00, 34.01.30.00, 34.02.11.10, 34.02.11.90, 34.02.12.10, 34.02.12.90 and 34.02.13.10. ;
Regulation Type: Regular notification
Ordinance Nº 53, 13 October 2013 (Instrução Normativa nº 53, de 23 de outubro de 2013) determines criteria for definitions, classification, establishment registration and importation of fertilizers, liming, inoculants, agricultural biofertilizers or secondary materials. ; ; (34 pages, in Portuguese).
Distribution date: 14 November 2013
<p style="margin:6pt 0cm;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>T</span>echnical regulation and </span><span lang="EN-GB">assessment procedures </span></span><span lang="EN-GB">establishing </span><span lang="EN-GB">provisions, criteria, inspection and supervision for the production and trade of fertilizers, liming, inoculants, agricultural biofertilizers </span><span style="font-face:Verdana;">or secondary materials</span><span lang="EN-GB">.</span></p><span><span style="font-size:small;font-face:Verdana;"><span style="font-family:'Verdana', 'sans-serif';background:white;font-size:10pt;">It revokes Ordinance Nº. 10, 6 May 2004 and Ordinance Nº. 20, 2 June 2009</span></span></span><span style="color:blue;font-size:medium;font-face:Times New Roman;"><span style="font-family:'Times New Roman', 'serif';color:blue;font-size:12pt;"> </span></span><span style="color:black;font-size:x-small;font-face:Verdana;"><span style="font-family:'Verdana', 'sans-serif';color:black;font-size:9pt;">(Instrução Normativa Nº 10, de 6 de maio de 2004 e a Instrução Normativa Nº 20, de 2 de junho de 2009).</span></span>
Products Covered: Fertilizers, liming, inoculants, agricultural biofertilizers or secondary materials (HS 31)
Regulation Type: Regular notification
Ordinance Nº 53, 13 October 2013 (Instrução Normativa nº 53, de 23 de outubro de 2013) determines criteria for definitions, classification, establishment registration and importation of fertilizers, liming, inoculants, agricultural biofertilizers or secondary materials. ; ; (34 pages, in Portuguese).
Distribution date: 14 November 2013
<p style="margin:6pt 0cm;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>T</span>echnical regulation and </span><span lang="EN-GB">assessment procedures </span></span><span lang="EN-GB">establishing </span><span lang="EN-GB">provisions, criteria, inspection and supervision for the production and trade of fertilizers, liming, inoculants, agricultural biofertilizers </span><span style="font-face:Verdana;">or secondary materials</span><span lang="EN-GB">.</span></p><span><span style="font-size:small;font-face:Verdana;"><span style="font-family:'Verdana', 'sans-serif';background:white;font-size:10pt;">It revokes Ordinance Nº. 10, 6 May 2004 and Ordinance Nº. 20, 2 June 2009</span></span></span><span style="color:blue;font-size:medium;font-face:Times New Roman;"><span style="font-family:'Times New Roman', 'serif';color:blue;font-size:12pt;"> </span></span><span style="color:black;font-size:x-small;font-face:Verdana;"><span style="font-family:'Verdana', 'sans-serif';color:black;font-size:9pt;">(Instrução Normativa Nº 10, de 6 de maio de 2004 e a Instrução Normativa Nº 20, de 2 de junho de 2009).</span></span>
Products Covered: Fertilizers, liming, inoculants, agricultural biofertilizers or secondary materials (HS 31)
Regulation Type: Regular notification
Notice of Consultation - Prescription Drug List: Diclofenac (2 pages, in English; 2 pages, in French).
Distribution date: 13 November 2013 | Final date for Comment: 12 January 2014
<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:Calibri;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-bidi-font-size:11.0pt;">The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to increase the non-prescription concentration of Diclofenac from 1% to 2% in topical preparations for human use.</span></span>
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)
Regulation Type: Regular notification
Notice of Consultation - Prescription Drug List: Diclofenac (2 pages, in English; 2 pages, in French).
Distribution date: 13 November 2013 | Final date for Comment: 12 January 2014
<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:Calibri;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-bidi-font-size:11.0pt;">The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to increase the non-prescription concentration of Diclofenac from 1% to 2% in topical preparations for human use.</span></span>
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)
Regulation Type: Regular notification
Notice of Consultation- Prescription Drug List (PDL): Minoxidil (2 pages, in English; 2 pages, in French).
Distribution date: 13 November 2013 | Final date for Comment: 12 January 2014
<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-family:'Verdana','sans-serif';font-size:9pt;">The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to increase the non-prescription concentrations of Minoxidil from 2% to %5 in topical preparations. <span> </span></span></span>
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)
Regulation Type: Regular notification
Notice of Consultation- Prescription Drug List (PDL): Minoxidil (2 pages, in English; 2 pages, in French).
Distribution date: 13 November 2013 | Final date for Comment: 12 January 2014
<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-family:'Verdana','sans-serif';font-size:9pt;">The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to increase the non-prescription concentrations of Minoxidil from 2% to %5 in topical preparations. <span> </span></span></span>
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)
Regulation Type: Regular notification
Notice of Consultation - Prescription Drug List (PDL): Omeprazole (2 pages, in English; 2 pages, in French).
Distribution date: 13 November 2013 | Final date for Comment: 12 January 2014
<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:Calibri;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-bidi-font-size:11.0pt;">The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to revise the Human Prescription Drug List for Omeprazole or its salts to be sold as a non-prescription product when sold as a 14-day treatment of frequent heartburn at a daily dose of 20 mg.</span></span>
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)
Regulation Type: Regular notification
Notice of Consultation - Prescription Drug List (PDL): Omeprazole (2 pages, in English; 2 pages, in French).
Distribution date: 13 November 2013 | Final date for Comment: 12 January 2014
<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:Calibri;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-bidi-font-size:11.0pt;">The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to revise the Human Prescription Drug List for Omeprazole or its salts to be sold as a non-prescription product when sold as a 14-day treatment of frequent heartburn at a daily dose of 20 mg.</span></span>
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)
Regulation Type: Regular notification
Partial revision of the Japanese Pharmacopoeia, Sixteenth edition (6 pages, in English).
Distribution date: 13 November 2013 | Final date for Comment: 12 January 2014
Under the provision of Article 41 of the Pharmaceutical Affairs Law, the Japanese Pharmacopoeia, Sixteenth edition is to be revised.
Products Covered: Drugs(HS:30)
Regulation Type: Regular notification
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