Regulatory Updates

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

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

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

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.&nbsp;<span>&nbsp;&nbsp;</span></span></span>

Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)

Regulation Type: Regular notification

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.&nbsp;<span>&nbsp;&nbsp;</span></span></span>

Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)

Regulation Type: Regular notification

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

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

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

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

Distribution date: 11 November 2013 | Final date for Comment: 10 January 2014

Proposed maximum residue limits (MRLs) for the following agricultural chemicals: Pesticide: Dicamba Veterinary drug/feed additive: Narasin

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, birds' eggs and natural honey (HS Codes: 04.01, 04.07 and 04.08) - Products of animal origin (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.08, 07.09 and 07.10) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.07 and 12.12) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification